Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT02305368
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4
Sponsor:
University Hospital, Limoges
Organization:
Study Overview
Official Title:
Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4: a Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oncogramme
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.
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).
* 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: