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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
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 27, 2019
Last Updated
October 5, 2021
Sponsor
Centre Oscar Lambret
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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
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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

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Feasibility of a New Technology for Isolating Circulating Tumour Cells

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