BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer

• Conditions: Rectum Cancer; Cancer of Colon
• Interventions: Genetic: Genetic analysis on tumor kept in tumor bank

• Registration Number: NCT02458664
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 597

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colo-rectal cancer	Genetic analysis on tumor kept in tumor bank	All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital

Primary Outcome Measures

Name	Time	Method
Recurrence free survival and Recurrence free survival after resection of the colon cancer	End of follow up : at least 3 years	3 years for prospective patients, more for retrospective patients

Secondary Outcome Measures

Name	Time	Method
Overall survival	End of follow up : at least 3 years	3 years for prospective patients, more for retrospective patients

Trial Locations

Locations (1)

Department of Digestive Surgery, Hôpital Saint-Antoine; 🇫🇷 Paris, France