Colon CancerOncogrammeNCT02305368
Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4
An observational study of Colon Cancer, run by University Hospital, Limoges.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Chimio-oncogramme
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2013
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
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).
- Conditions
- Colon Cancer
- Being tested
- Chimio-oncogramme
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimio-oncogrammeOther
Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chimio-oncogramme |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro analysis of chemotherapy responses
Evaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)
Measured: 7 days
Secondary outcomes (1)
quality of life
Evaluate the predictive value of chemo-oncogramme on chemical toxicity and quality of life of patients.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel MATHONNET, MD, Principal investigator, Chirurgie digestive - CHU LIMOGES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305368
- Sponsor's protocol ID
- I09019 Oncogramme colon
- Acronym
- Oncogramme
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4: a Pilot Study
- ClinicalTrials.gov ID
- NCT02305368
- Acronym / sponsor ID
- Oncogramme / I09019 Oncogramme colon
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncogramme | – | Other: Chimio-oncogrammeTaking 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimio-oncogrammeCells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme. | Other | Oncogramme |
Primary outcome
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)
1 secondary outcome
quality of life
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 26791256Bounaix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muriel MATHONNET, MD principal investigator
Chirurgie digestive - CHU LIMOGES
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by University Hospital, Limoges.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro analysis of chemotherapy responses (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.