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CompletedNCT02305368OncogrammeUpdated Dec 2, 2014

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

An observational study in Colon Cancer, sponsored by University Hospital, Limoges. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by University Hospital, Limoges · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Colon Cancer

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 20 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherChimio-oncogramme

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

06

What researchers measure

Primary outcomes

  1. In vitro analysis of chemotherapy responses

    Evaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)

    Time frame: 7 days

Secondary outcomes

  1. quality of life

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

    Time frame: 7 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26791256 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02305368
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Dec 2, 2014
Start date
Mar 2011
Primary completion
Mar 2012
Completion
Mar 2013
Last update
Dec 2, 2014

Study contacts

Muriel MATHONNET, MD
principal investigator · Chirurgie digestive - CHU LIMOGES

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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