Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02305368
Acronym
Oncogramme
Enrollment
20
Registered
2014-12-02
Start date
2011-03-31
Completion date
2013-03-31
Last updated
2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

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).

Interventions

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
In vitro analysis of chemotherapy responses7 daysEvaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)

Secondary

MeasureTime frameDescription
quality of life7 daysEvaluate the predictive value of chemo-oncogramme on chemical toxicity and quality of life of patients.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026