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NCT Number: NCT02305368

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chimio-oncogramme

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. quality of life

    Time frame: 7 days

    Evaluate the predictive value of chemo-oncogramme on chemical toxicity and quality of life of patients.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: Oncogramme

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 2, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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