Tumoral Circulating Cells and Colorectal Cancer Progression

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Blood and tumor samples

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle BOQUET, PhD; Phone Number: +33 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
    • Contact: Jean-Luc RAOUL, MD; Phone Number: 33491223778; Email: drci.up@ipc.unicancer.fr
    • Principal Investigator: Jean-Luc RAOUL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colorectal Cancer; 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.	Procedure: Blood and tumor samples; Blood and tumor samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Beckman Coulter, Inc.
• Investigators: Study Director: Jean-Luc RAOUL, Pr, Institut Paoli-Calmettes

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Official website of the sponsor

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CTC-Côlon-IPC 2015-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No