Feasibility of a New Technology for Isolating Circulating Tumour Cells (CTC-SMMiL-E)
Primary Purpose
HER2-positive Metastatic Breast Cancer, Ovarian Cancer, Hormone-resistant Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
About this trial
This is an interventional other trial for HER2-positive Metastatic Breast Cancer focused on measuring Circulating Tumour Cells, Selected cancer patients, New technology
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Registered with a social security system
- Signed, IRB-approved written informed consent
- Belonging to one of the following group:
- Group 1 - HER-2 positive breast cancer, defined as followed: histologically-proven, HER-2 positive breast cancer, with metastasis (stage IV) requiring first-line treatment
- Group 2 - Advanced ovarian cancer, defined as followed: histologically-proven, stage III or IV ovarian cancer requiring first-line chemotherapy
- Group 3 - Metastatic prostate cancer, defined as followed: histologically-proven, stage IV, castrate-resistant prostate cancer requiring chemotherapy with docetaxel or treatment with 2nd generation hormonal therapy (e.g. enzalutamide or abiraterone)
- Groups 0 and 4 - Healthy volunteers defined as followed: No prior personal history of malignant disease
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Patient under guardianship or curatorship
Sites / Locations
- Centre Oscar LambretRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
blood sample collection
Arm Description
For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes)
Outcomes
Primary Outcome Measures
Percentage of cases with identified circulating tumor cells.
To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.
In each group, the percentage of cases with identified circulating tumor cells will be estimated.
Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.
Failure: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.
To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
CA 125-positive using immuno-histochemistry (IHC) (Group 2)
PSA-positive using IHC (Group 3)
Secondary Outcome Measures
Description of the isolated circulating cell
Describe the different characteristics of these cells: size, cytological characteristics, number ...
These informations will allow to characterize the isolated circulating cells.
Percentage of cases with identified circulating tumor cells after frozen storage
To assess the ability of the new technology to isolating CTC
As secondary collected, collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to our capacity for isolating the CTC.
In each group, the percentage of cases with identified circulating tumor cells will be estimated.
To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
CA 125-positive using immuno-histochemistry (IHC) (Group 2)
PSA-positive using IHC (Group 3)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03979339
Brief Title
Feasibility of a New Technology for Isolating Circulating Tumour Cells
Acronym
CTC-SMMiL-E
Official Title
Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective interventional single-site research with a collection of biological samples.
The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.
Five groups will be constitued: at first the Group 0: Healthy volunteers included for the spike-in test; and then the four groups, Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer; Group 4: Healthy volunteers included as control).
In each group, the percentage of cases with identified circulating tumor cells will be estimated.
Detailed Description
This is a prospective interventional single-site research with a collection of biological samples ("Recherche Impliquant la Personne Humaine de type 2" according to French legislation).
First, a cohort of 20 healthy volunteers (Group 0: Healthy volunteers included for the spike-in test) will be constituted for the spike-in-test.
Then, recruitment of the three groups of 14 patients each (Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer) and the control group of 14 healthy volunteers (Group 4: Healthy volunteers included as control) will be done in parallel.
In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success will be defined as follows: the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.
Circulating tumor cells (CTC) will be identified as followed:
Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization (FISH) to be regarded as true CTC
Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry (IHC) to be regarded as true CTC
Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls, if putative circulating cells are observed, these healthy volunteers will be tested against the three markers (HER2, CA-125 and PSA).
Failure will be defined as follows: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.
The different characteristics of these cells will be described: size, cytological characteristics, number, etc.
Secondary collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC.
The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Metastatic Breast Cancer, Ovarian Cancer, Hormone-resistant Prostate Cancer, Circulating Tumor Cell
Keywords
Circulating Tumour Cells, Selected cancer patients, New technology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
blood sample collection
Arm Type
Experimental
Arm Description
For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes)
Intervention Type
Procedure
Intervention Name(s)
Blood sample collection
Intervention Description
A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each.
Primary Outcome Measure Information:
Title
Percentage of cases with identified circulating tumor cells.
Description
To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.
In each group, the percentage of cases with identified circulating tumor cells will be estimated.
Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.
Failure: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.
To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
CA 125-positive using immuno-histochemistry (IHC) (Group 2)
PSA-positive using IHC (Group 3)
Time Frame
within 24 hours after inclusion (blood sample collection)
Secondary Outcome Measure Information:
Title
Description of the isolated circulating cell
Description
Describe the different characteristics of these cells: size, cytological characteristics, number ...
These informations will allow to characterize the isolated circulating cells.
Time Frame
within 24 hours after inclusion (blood sample collection)
Title
Percentage of cases with identified circulating tumor cells after frozen storage
Description
To assess the ability of the new technology to isolating CTC
As secondary collected, collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to our capacity for isolating the CTC.
In each group, the percentage of cases with identified circulating tumor cells will be estimated.
To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
CA 125-positive using immuno-histochemistry (IHC) (Group 2)
PSA-positive using IHC (Group 3)
Time Frame
within 24 hours after inclusion (blood sample collection)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Registered with a social security system
Signed, IRB-approved written informed consent
Belonging to one of the following group:
Group 1 - HER-2 positive breast cancer, defined as followed: histologically-proven, HER-2 positive breast cancer, with metastasis (stage IV) requiring first-line treatment
Group 2 - Advanced ovarian cancer, defined as followed: histologically-proven, stage III or IV ovarian cancer requiring first-line chemotherapy
Group 3 - Metastatic prostate cancer, defined as followed: histologically-proven, stage IV, castrate-resistant prostate cancer requiring chemotherapy with docetaxel or treatment with 2nd generation hormonal therapy (e.g. enzalutamide or abiraterone)
Groups 0 and 4 - Healthy volunteers defined as followed: No prior personal history of malignant disease
Exclusion Criteria:
Pregnant or breastfeeding woman
Patient under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Vanseymortier
Phone
+33 (0)3 20 29 59 18
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie KACZMAREK, MD
Organizational Affiliation
Medical Oncology Department - Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie KACZMAREK, MD
Phone
03 20 29 59 59
Email
e-kaczmarek@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Emilie KACZMAREK, MD
First Name & Middle Initial & Last Name & Degree
Audrey MAILLIEZ, MD
First Name & Middle Initial & Last Name & Degree
Nicolas PENEL, MD, PhD
First Name & Middle Initial & Last Name & Degree
Delphine HUDRY, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22733306
Citation
Bednarz-Knoll N, Alix-Panabieres C, Pantel K. Plasticity of disseminating cancer cells in patients with epithelial malignancies. Cancer Metastasis Rev. 2012 Dec;31(3-4):673-87. doi: 10.1007/s10555-012-9370-z.
Results Reference
background
PubMed Identifier
15501967
Citation
Allard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904. doi: 10.1158/1078-0432.CCR-04-0378.
Results Reference
background
PubMed Identifier
15317891
Citation
Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
Results Reference
background
PubMed Identifier
15735118
Citation
Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005 Mar 1;23(7):1420-30. doi: 10.1200/JCO.2005.08.140. Erratum In: J Clin Oncol. 2005 Jul 20;23(21):4808.
Results Reference
background
PubMed Identifier
17289886
Citation
Riethdorf S, Fritsche H, Muller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Janicke F, Jackson S, Gornet T, Cristofanilli M, Pantel K. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res. 2007 Feb 1;13(3):920-8. doi: 10.1158/1078-0432.CCR-06-1695.
Results Reference
background
PubMed Identifier
18553236
Citation
Yagata H, Nakamura S, Toi M, Bando H, Ohno S, Kataoka A. Evaluation of circulating tumor cells in patients with breast cancer: multi-institutional clinical trial in Japan. Int J Clin Oncol. 2008 Jun;13(3):252-6. doi: 10.1007/s10147-007-0748-9. Epub 2008 Jun 14.
Results Reference
background
PubMed Identifier
18392713
Citation
Kurihara T, Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Tsuji S, Ishii K, Ikeuchi N, Tsuchida A, Kasuya K, Kawai T, Sakai Y, Moriyasu F. Detection of circulating tumor cells in patients with pancreatic cancer: a preliminary result. J Hepatobiliary Pancreat Surg. 2008;15(2):189-95. doi: 10.1007/s00534-007-1250-5. Epub 2008 Apr 6.
Results Reference
background
PubMed Identifier
22187035
Citation
Khoja L, Backen A, Sloane R, Menasce L, Ryder D, Krebs M, Board R, Clack G, Hughes A, Blackhall F, Valle JW, Dive C. A pilot study to explore circulating tumour cells in pancreatic cancer as a novel biomarker. Br J Cancer. 2012 Jan 31;106(3):508-16. doi: 10.1038/bjc.2011.545. Epub 2011 Dec 20.
Results Reference
background
PubMed Identifier
18596266
Citation
Maheswaran S, Sequist LV, Nagrath S, Ulkus L, Brannigan B, Collura CV, Inserra E, Diederichs S, Iafrate AJ, Bell DW, Digumarthy S, Muzikansky A, Irimia D, Settleman J, Tompkins RG, Lynch TJ, Toner M, Haber DA. Detection of mutations in EGFR in circulating lung-cancer cells. N Engl J Med. 2008 Jul 24;359(4):366-77. doi: 10.1056/NEJMoa0800668. Epub 2008 Jul 2.
Results Reference
background
PubMed Identifier
18097410
Citation
Nagrath S, Sequist LV, Maheswaran S, Bell DW, Irimia D, Ulkus L, Smith MR, Kwak EL, Digumarthy S, Muzikansky A, Ryan P, Balis UJ, Tompkins RG, Haber DA, Toner M. Isolation of rare circulating tumour cells in cancer patients by microchip technology. Nature. 2007 Dec 20;450(7173):1235-9. doi: 10.1038/nature06385.
Results Reference
background
PubMed Identifier
20930119
Citation
Stott SL, Hsu CH, Tsukrov DI, Yu M, Miyamoto DT, Waltman BA, Rothenberg SM, Shah AM, Smas ME, Korir GK, Floyd FP Jr, Gilman AJ, Lord JB, Winokur D, Springer S, Irimia D, Nagrath S, Sequist LV, Lee RJ, Isselbacher KJ, Maheswaran S, Haber DA, Toner M. Isolation of circulating tumor cells using a microvortex-generating herringbone-chip. Proc Natl Acad Sci U S A. 2010 Oct 26;107(43):18392-7. doi: 10.1073/pnas.1012539107. Epub 2010 Oct 7.
Results Reference
background
PubMed Identifier
20424012
Citation
Stott SL, Lee RJ, Nagrath S, Yu M, Miyamoto DT, Ulkus L, Inserra EJ, Ulman M, Springer S, Nakamura Z, Moore AL, Tsukrov DI, Kempner ME, Dahl DM, Wu CL, Iafrate AJ, Smith MR, Tompkins RG, Sequist LV, Toner M, Haber DA, Maheswaran S. Isolation and characterization of circulating tumor cells from patients with localized and metastatic prostate cancer. Sci Transl Med. 2010 Mar 31;2(25):25ra23. doi: 10.1126/scitranslmed.3000403.
Results Reference
background
PubMed Identifier
22683404
Citation
Cen P, Ni X, Yang J, Graham DY, Li M. Circulating tumor cells in the diagnosis and management of pancreatic cancer. Biochim Biophys Acta. 2012 Dec;1826(2):350-6. doi: 10.1016/j.bbcan.2012.05.007. Epub 2012 Jun 7.
Results Reference
background
PubMed Identifier
16136352
Citation
Soeth E, Grigoleit U, Moellmann B, Roder C, Schniewind B, Kremer B, Kalthoff H, Vogel I. Detection of tumor cell dissemination in pancreatic ductal carcinoma patients by CK 20 RT-PCR indicates poor survival. J Cancer Res Clin Oncol. 2005 Oct;131(10):669-76. doi: 10.1007/s00432-005-0008-1. Epub 2005 Sep 1.
Results Reference
background
PubMed Identifier
17226905
Citation
Hoffmann K, Kerner C, Wilfert W, Mueller M, Thiery J, Hauss J, Witzigmann H. Detection of disseminated pancreatic cells by amplification of cytokeratin-19 with quantitative RT-PCR in blood, bone marrow and peritoneal lavage of pancreatic carcinoma patients. World J Gastroenterol. 2007 Jan 14;13(2):257-63. doi: 10.3748/wjg.v13.i2.257.
Results Reference
background
PubMed Identifier
22270149
Citation
de Albuquerque A, Kubisch I, Breier G, Stamminger G, Fersis N, Eichler A, Kaul S, Stolzel U. Multimarker gene analysis of circulating tumor cells in pancreatic cancer patients: a feasibility study. Oncology. 2012;82(1):3-10. doi: 10.1159/000335479. Epub 2012 Jan 20.
Results Reference
background
PubMed Identifier
23014601
Citation
Alix-Panabieres C, Pantel K. Circulating tumor cells: liquid biopsy of cancer. Clin Chem. 2013 Jan;59(1):110-8. doi: 10.1373/clinchem.2012.194258. Epub 2012 Sep 26.
Results Reference
background
PubMed Identifier
26050619
Citation
Pantel K, Speicher MR. The biology of circulating tumor cells. Oncogene. 2016 Mar 10;35(10):1216-24. doi: 10.1038/onc.2015.192. Epub 2015 Jun 8.
Results Reference
background
PubMed Identifier
24888818
Citation
Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2.
Results Reference
background
PubMed Identifier
24202397
Citation
Wan L, Pantel K, Kang Y. Tumor metastasis: moving new biological insights into the clinic. Nat Med. 2013 Nov;19(11):1450-64. doi: 10.1038/nm.3391.
Results Reference
background
PubMed Identifier
27630154
Citation
Gorges TM, Kuske A, Rock K, Mauermann O, Muller V, Peine S, Verpoort K, Novosadova V, Kubista M, Riethdorf S, Pantel K. Accession of Tumor Heterogeneity by Multiplex Transcriptome Profiling of Single Circulating Tumor Cells. Clin Chem. 2016 Nov;62(11):1504-1515. doi: 10.1373/clinchem.2016.260299. Epub 2016 Sep 14.
Results Reference
background
PubMed Identifier
27507192
Citation
Zhang Z, Shiratsuchi H, Palanisamy N, Nagrath S, Ramnath N. Expanded Circulating Tumor Cells from a Patient with ALK-Positive Lung Cancer Present with EML4-ALK Rearrangement Along with Resistance Mutation and Enable Drug Sensitivity Testing: A Case Study. J Thorac Oncol. 2017 Feb;12(2):397-402. doi: 10.1016/j.jtho.2016.07.027. Epub 2016 Aug 6.
Results Reference
background
PubMed Identifier
27556950
Citation
Jordan NV, Bardia A, Wittner BS, Benes C, Ligorio M, Zheng Y, Yu M, Sundaresan TK, Licausi JA, Desai R, O'Keefe RM, Ebright RY, Boukhali M, Sil S, Onozato ML, Iafrate AJ, Kapur R, Sgroi D, Ting DT, Toner M, Ramaswamy S, Haas W, Maheswaran S, Haber DA. HER2 expression identifies dynamic functional states within circulating breast cancer cells. Nature. 2016 Sep 1;537(7618):102-106. doi: 10.1038/nature19328. Epub 2016 Aug 24.
Results Reference
background
PubMed Identifier
21896640
Citation
van de Stolpe A, Pantel K, Sleijfer S, Terstappen LW, den Toonder JM. Circulating tumor cell isolation and diagnostics: toward routine clinical use. Cancer Res. 2011 Sep 15;71(18):5955-60. doi: 10.1158/0008-5472.CAN-11-1254. Epub 2011 Sep 6.
Results Reference
background
PubMed Identifier
22591372
Citation
Gorges TM, Tinhofer I, Drosch M, Rose L, Zollner TM, Krahn T, von Ahsen O. Circulating tumour cells escape from EpCAM-based detection due to epithelial-to-mesenchymal transition. BMC Cancer. 2012 May 16;12:178. doi: 10.1186/1471-2407-12-178.
Results Reference
background
PubMed Identifier
27711186
Citation
Vila A, Abal M, Muinelo-Romay L, Rodriguez-Abreu C, Rivas J, Lopez-Lopez R, Costa C. EGFR-Based Immunoisolation as a Recovery Target for Low-EpCAM CTC Subpopulation. PLoS One. 2016 Oct 6;11(10):e0163705. doi: 10.1371/journal.pone.0163705. eCollection 2016.
Results Reference
background
PubMed Identifier
20379845
Citation
Mostert B, Kraan J, Bolt-de Vries J, van der Spoel P, Sieuwerts AM, Schutte M, Timmermans AM, Foekens R, Martens JW, Gratama JW, Foekens JA, Sleijfer S. Detection of circulating tumor cells in breast cancer may improve through enrichment with anti-CD146. Breast Cancer Res Treat. 2011 May;127(1):33-41. doi: 10.1007/s10549-010-0879-y. Epub 2010 Apr 9.
Results Reference
background
PubMed Identifier
20116432
Citation
Alunni-Fabbroni M, Sandri MT. Circulating tumour cells in clinical practice: Methods of detection and possible characterization. Methods. 2010 Apr;50(4):289-97. doi: 10.1016/j.ymeth.2010.01.027. Epub 2010 Jan 29.
Results Reference
background
PubMed Identifier
24633084
Citation
Lowes LE, Allan AL. Recent advances in the molecular characterization of circulating tumor cells. Cancers (Basel). 2014 Mar 13;6(1):595-624. doi: 10.3390/cancers6010595.
Results Reference
background
PubMed Identifier
10623654
Citation
Vona G, Sabile A, Louha M, Sitruk V, Romana S, Schutze K, Capron F, Franco D, Pazzagli M, Vekemans M, Lacour B, Brechot C, Paterlini-Brechot P. Isolation by size of epithelial tumor cells : a new method for the immunomorphological and molecular characterization of circulatingtumor cells. Am J Pathol. 2000 Jan;156(1):57-63. doi: 10.1016/S0002-9440(10)64706-2.
Results Reference
background
PubMed Identifier
21829190
Citation
Farace F, Massard C, Vimond N, Drusch F, Jacques N, Billiot F, Laplanche A, Chauchereau A, Lacroix L, Planchard D, Le Moulec S, Andre F, Fizazi K, Soria JC, Vielh P. A direct comparison of CellSearch and ISET for circulating tumour-cell detection in patients with metastatic carcinomas. Br J Cancer. 2011 Sep 6;105(6):847-53. doi: 10.1038/bjc.2011.294. Epub 2011 Aug 9.
Results Reference
background
PubMed Identifier
20978853
Citation
Zheng S, Lin HK, Lu B, Williams A, Datar R, Cote RJ, Tai YC. 3D microfilter device for viable circulating tumor cell (CTC) enrichment from blood. Biomed Microdevices. 2011 Feb;13(1):203-13. doi: 10.1007/s10544-010-9485-3.
Results Reference
background
PubMed Identifier
24577360
Citation
Karabacak NM, Spuhler PS, Fachin F, Lim EJ, Pai V, Ozkumur E, Martel JM, Kojic N, Smith K, Chen PI, Yang J, Hwang H, Morgan B, Trautwein J, Barber TA, Stott SL, Maheswaran S, Kapur R, Haber DA, Toner M. Microfluidic, marker-free isolation of circulating tumor cells from blood samples. Nat Protoc. 2014 Mar;9(3):694-710. doi: 10.1038/nprot.2014.044. Epub 2014 Feb 27.
Results Reference
background
PubMed Identifier
23552373
Citation
Ozkumur E, Shah AM, Ciciliano JC, Emmink BL, Miyamoto DT, Brachtel E, Yu M, Chen PI, Morgan B, Trautwein J, Kimura A, Sengupta S, Stott SL, Karabacak NM, Barber TA, Walsh JR, Smith K, Spuhler PS, Sullivan JP, Lee RJ, Ting DT, Luo X, Shaw AT, Bardia A, Sequist LV, Louis DN, Maheswaran S, Kapur R, Haber DA, Toner M. Inertial focusing for tumor antigen-dependent and -independent sorting of rare circulating tumor cells. Sci Transl Med. 2013 Apr 3;5(179):179ra47. doi: 10.1126/scitranslmed.3005616.
Results Reference
background
PubMed Identifier
28586395
Citation
Jaeger BAS, Neugebauer J, Andergassen U, Melcher C, Schochter F, Mouarrawy D, Ziemendorff G, Clemens M, V Abel E, Heinrich G, Schueller K, Schneeweiss A, Fasching P, Beckmann MW, Scholz C, Friedl TWP, Friese K, Pantel K, Fehm T, Janni W, Rack B. The HER2 phenotype of circulating tumor cells in HER2-positive early breast cancer: A translational research project of a prospective randomized phase III trial. PLoS One. 2017 Jun 6;12(6):e0173593. doi: 10.1371/journal.pone.0173593. eCollection 2017.
Results Reference
background
PubMed Identifier
27456503
Citation
Zhang S, Li L, Wang T, Bian L, Hu H, Xu C, Liu B, Liu Y, Cristofanilli M, Jiang Z. Real-time HER2 status detected on circulating tumor cells predicts different outcomes of anti-HER2 therapy in histologically HER2-positive metastatic breast cancer patients. BMC Cancer. 2016 Jul 25;16:526. doi: 10.1186/s12885-016-2578-5.
Results Reference
background
PubMed Identifier
26083256
Citation
Agelaki S, Kalykaki A, Markomanolaki H, Papadaki MA, Kallergi G, Hatzidaki D, Kalbakis K, Mavroudis D, Georgoulias V. Efficacy of Lapatinib in Therapy-Resistant HER2-Positive Circulating Tumor Cells in Metastatic Breast Cancer. PLoS One. 2015 Jun 17;10(6):e0123683. doi: 10.1371/journal.pone.0123683. eCollection 2015.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29290959
Description
Circulating tumor cells: potential markers of minimal residual disease in ovarian cancer? a study of the OVCAD consortium
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697683/
Description
The added value of circulating tumor cells examination in ovarian cancer staging
URL
https://www.ncbi.nlm.nih.gov/pubmed/26923772
Description
Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer
Learn more about this trial
Feasibility of a New Technology for Isolating Circulating Tumour Cells
We'll reach out to this number within 24 hrs