BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer (BASE HSP110)
November 30, 2015 updated by: Assistance Publique - Hôpitaux de Paris
We collect prospectively and retrospectively, patients' demographic, pathological, surgical, therapeutic and prognosis informations in a database. After patient's consent to collect tumoural samples of their colorectal cancer after resection.
We will then be able to evaluate the impact of HSP110, a chaperon protein, on their prognosis. Other proteins (to be determined) will also be study, after.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To investigate the importance of HSP110DE9 as a prognostic marker for colorectal cancer, we will analyze genotyping fluorescence quantitative RT-PCR and / or immunomarquage the presence of this mutant in a large cohort of patients (more than 2000 patients had or having a colorectal cancer).
All patients have been or will be made in general and digestive surgery department at Saint-Antoine hospital.
Tumor fragments samples were or will be made on their tumor and keep it in the tumor bank of the Saint-Antoine hospital.
All patients reported their no objection to the use of these tumor fragments for research purposes.
A database will be built and correlated with the tumor fragments.
This project is intended that the constitution of a clinical database including prognostic so that we make discoveries on HSP110DE9 or other molecular biology to discover markers can be correlated with clinical data.
In the absence of other studies on the subject, with no real knowledge of the prognostic impact of this mutant, we cannot provide an effective computation.
We therefore propose to make a database of 2000 patients retrospectively and prospectively to obtain statistical results valid and powerful.
Study Type
Observational
Enrollment (Actual)
597
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75012
- Department of Digestive Surgery, Hôpital Saint-Antoine
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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
Non-Probability Sample
Study Population
Patients, male or female, over 18 years, undergoing curative colorectal resection
Description
Inclusion Criteria:
- All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital.
- Patients reporting their non-opposition to the use of tissue samples taken from their specimen for research purposes.
Exclusion Criteria:
- Patients who did not report their non-opposition to the use of tissue samples taken from their specimen for research purposes.
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 |
|---|---|
|
Colo-rectal cancer
All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence free survival and Recurrence free survival after resection of the colon cancer
Time Frame: End of follow up : at least 3 years
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3 years for prospective patients, more for retrospective patients
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End of follow up : at least 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: End of follow up : at least 3 years
|
3 years for prospective patients, more for retrospective patients
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End of follow up : at least 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
November 1, 2013
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
May 27, 2015
First Submitted That Met QC Criteria
May 28, 2015
First Posted (Estimate)
June 1, 2015
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI12029
- 2013-A01080-45 (Other Grant/Funding Number: N° ID RCB)
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.