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

November 26, 2014 updated by: University Hospital, Limoges

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Chimio-oncogramme
Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In vitro analysis of chemotherapy responses
Time Frame: 7 days
Evaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 7 days
Evaluate the predictive value of chemo-oncogramme on chemical toxicity and quality of life of patients.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Muriel MATHONNET, MD, Chirurgie digestive - CHU LIMOGES

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I09019 Oncogramme colon

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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