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

Colon Cancer Clinical Trial

— Oncogramme  

Official title:

Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305368
• Other study ID #: I09019 Oncogramme colon
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: November 26, 2014
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2014
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Colon Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vitro analysis of chemotherapy responses	Evaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)	7 days	No
Secondary	quality of life	Evaluate the predictive value of chemo-oncogramme on chemical toxicity and quality of life of patients.	7 days	No