Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4

NCT ID: NCT02305368

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-03-31

Brief Summary

In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases (lung and liver metastases), treatment with chemotherapy is necessary but not end in success in 10% of cases. The development of techniques for administering personalized treatment becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these patients and evaluating the effect of chemotherapy on these could be made for each patient. In France, the company develops Oncomedics these tests.

This is a pilot study that will make a first evaluation under actual conditions of chimio-oncogramme.

Detailed Description

A fragment of colon tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with colon carcinoma metastatic (stage 4). In parallel and systematically: analysis by the pathologist of a histological section.

• Culturing the cells obtained from the tumor by Oncomedics fragment in a defined medium and provided for enriching tumor cells compared to stromal cells.
• Maintaining the cells in culture for 7 days.
• Effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by Oncomedics (chimio-oncogramme).
• For each chemotherapy tested, measuring the proportion of dead cells / total cells.
• Retained by Oncomedics results, not given to the nursing team. The patient will be treated and followed up in the usual way.
• At the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient's response to (x) the same (s) chemotherapy (s).

Conditions

Colon Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oncogramme

Taking a fragment of colon tumors taken from a specimen. Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.

Chimio-oncogramme

Intervention Type: OTHER

Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.

Interventions

Chimio-oncogramme

Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy
• targets must be measurable tumor lesions (RECIST)
• patient has not expressed opposition to the use of their residual tumor

Exclusion Criteria

• Against-formal indication to an indispensable para-clinical examination of the patient monitoring
• Use of chemotherapy, hormone therapy or concomitant radiotherapy
• Cons-indication for chemotherapy
• Are pregnant, nursing or lack of contraception for women of childbearing age.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muriel MATHONNET, MD

Role: PRINCIPAL_INVESTIGATOR

Chirurgie digestive - CHU LIMOGES

References

Bounaix Morand du Puch C, Nouaille M, Giraud S, Labrunie A, Luce S, Preux PM, Labrousse F, Gainant A, Tubiana-Mathieu N, Le Brun-Ly V, Valleix D, Guillaudeau A, Mesturoux L, Coulibaly B, Lautrette C, Mathonnet M. Chemotherapy outcome predictive effectiveness by the Oncogramme: pilot trial on stage-IV colorectal cancer. J Transl Med. 2016 Jan 12;14:10. doi: 10.1186/s12967-016-0765-4.

Reference Type: DERIVED

PMID: 26791256 (View on PubMed)

Other Identifiers

I09019 Oncogramme colon

Identifier Type: -

Identifier Source: org_study_id