Tumoral Circulating Cells and Colorectal Cancer Progression

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256084
• Other study ID #: CTC-Côlon-IPC 2015-020
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: May 2025

Study information

• Verified date: May 2021
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33 4 91 22 37 78
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2025
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Blood and tumor samples
Blood and tumor samples

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (3)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Beckman Coulter, Inc., Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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 — View 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. — View Citation

Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Viéitez JM, Alonso V, Grávalos C, Escudero P, Vera R, Aranda E, García-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, López-Ladrón A, Díaz-Rubio E. Role of circul — View 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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Official Website of the Sponsor