Back to results

Tumoral Circulating Cells and Colorectal Cancer Progression

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood and tumor samples

About this trial

This is an interventional basic science trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient of more than 18 years old
Histological diagnosis of colic adenocarcinoma metastatic or not
Before any treatment with systemic chemotherapy
Patient affiliated to, or beneficiating of the national security
Patient having signed informed consent

Exclusion Criteria:

Patient with previous chemothrapy treatment
Patient with more than one evolutive tumoral pathology
Patient under long-term immunosuppressor treatment
Patient with severe infection
Pregnant or breasting woman
Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.

Sites / Locations

Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colorectal Cancer

Arm Description

Localized stage II/III (group 1), metastatic non resectable (group 2), metastatic potentially resectable (group 3). Additional blood samples specific for the research will be collected. Tissue samples will be taken on surgical specimens from surgery.

Outcomes

Primary Outcome Measures

Evaluation of CTC features

Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.

Secondary Outcome Measures

Full Information

NCT ID

NCT03256084

First Posted

June 19, 2017

Last Updated

May 5, 2021

Sponsor

Institut Paoli-Calmettes

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France, Beckman Coulter, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03256084

Brief Title

Tumoral Circulating Cells and Colorectal Cancer Progression

Official Title

Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 17, 2017 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France, Beckman Coulter, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

Detailed Description

This study aims at allowing a better understanding of which circulating tumor cells (CTC) have the higher risk of metastasis of in the overall population of CTC. Prospective monocenter open-label study. In the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage II/III, metastatic non resectable, metastatic potentially resectable). Tissue samples will be collected for patients scheduled for surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colorectal Cancer

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Blood and tumor samples

Intervention Description

Blood and tumor samples

Primary Outcome Measure Information:

Title

Evaluation of CTC features

Description

Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.

Time Frame

Group 1: at surgery, 4 (+/- 1) weeks post-surgery, at progression. Group 2: before chemotherapy, after 4 months treatment (responders), at progression. Group 3: before neoadjuvant surgery, at surgery, 4 (+/- 1) weeks post-surgery, at progression.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient of more than 18 years old Histological diagnosis of colic adenocarcinoma metastatic or not Before any treatment with systemic chemotherapy Patient affiliated to, or beneficiating of the national security Patient having signed informed consent Exclusion Criteria: Patient with previous chemothrapy treatment Patient with more than one evolutive tumoral pathology Patient under long-term immunosuppressor treatment Patient with severe infection Pregnant or breasting woman Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique GENRE, MD

Phone

+33 4 91 22 37 78

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Isabelle BOQUET, PhD

Phone

+33 4 91 22 37 78

drci.up@ipc.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Luc RAOUL, Pr

Organizational Affiliation

Institut Paoli-Calmettes

Official's Role

Study Director

Facility Information:

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Luc RAOUL, MD

Phone

33491223778

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Jean-Luc RAOUL, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25515656

Citation

Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Vieitez JM, Alonso V, Gravalos C, Escudero P, Vera R, Aranda E, Garcia-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, Lopez-Ladron A, Diaz-Rubio E. Role of circulating tumor cells as prognostic marker in resected stage III colorectal cancer. Ann Oncol. 2015 Mar;26(3):535-41. doi: 10.1093/annonc/mdu568. Epub 2014 Dec 15.

Results Reference

result

PubMed Identifier

24880617

Citation

Hodgkinson CL, Morrow CJ, Li Y, Metcalf RL, Rothwell DG, Trapani F, Polanski R, Burt DJ, Simpson KL, Morris K, Pepper SD, Nonaka D, Greystoke A, Kelly P, Bola B, Krebs MG, Antonello J, Ayub M, Faulkner S, Priest L, Carter L, Tate C, Miller CJ, Blackhall F, Brady G, Dive C. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer. Nat Med. 2014 Aug;20(8):897-903. doi: 10.1038/nm.3600. Epub 2014 Jun 1.

Results Reference

result

PubMed Identifier

25013076

Citation

Yu M, Bardia A, Aceto N, Bersani F, Madden MW, Donaldson MC, Desai R, Zhu H, Comaills V, Zheng Z, Wittner BS, Stojanov P, Brachtel E, Sgroi D, Kapur R, Shioda T, Ting DT, Ramaswamy S, Getz G, Iafrate AJ, Benes C, Toner M, Maheswaran S, Haber DA. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014 Jul 11;345(6193):216-20. doi: 10.1126/science.1253533.

Results Reference

result

PubMed Identifier

26008969

Citation

Khoo BL, Lee SC, Kumar P, Tan TZ, Warkiani ME, Ow SG, Nandi S, Lim CT, Thiery JP. Short-term expansion of breast circulating cancer cells predicts response to anti-cancer therapy. Oncotarget. 2015 Jun 20;6(17):15578-93. doi: 10.18632/oncotarget.3903.

Results Reference

result

Links:

URL

http://institutpaolicalmettes.fr

Description

Official Website of the Sponsor

Learn more about this trial

Tumoral Circulating Cells and Colorectal Cancer Progression

We'll reach out to this number within 24 hrs