Clinical trial NCT02305368: Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4
Official title: Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy

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).

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.

Primary outcomes:
measure: In vitro analysis of chemotherapy responses
timeFrame: 7 days
Secondary outcomes:
measure: quality of life
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Chirurgie digestive - CHU LIMOGES
name: Muriel MATHONNET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.