Tumoral Circulating Cells and Colorectal Cancer Progression

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Blood and tumor samples

• Registration Number: NCT03256084
• Lead Sponsor: Institut Paoli-Calmettes

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.

Study Timeline

• Study First Submitted: 2017-06-19
• Study Start: 2017-07-17
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06
• Primary Completion: 2022-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

1. Patient with previous chemothrapy treatment
2. Patient with more than one evolutive tumoral pathology
3. Patient under long-term immunosuppressor treatment
4. Patient with severe infection
5. Pregnant or breasting woman
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer	Blood and tumor samples	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, France