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

Rectum Cancer Clinical Trial

— BASE HSP110  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02458664
• Other study ID #: NI12029
• Secondary ID: 2013-A01080-45
• Status: Active, not recruiting
• Phase: N/A
• First received: May 27, 2015
• Last updated: November 30, 2015
• Start date: November 2013
• Est. completion date: November 2018

Study information

• Verified date: November 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 597
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Cancer of Colon
• Colorectal Neoplasms
• Rectum Cancer

Intervention

Genetic:
• Genetic analysis on tumor kept in tumor bank

Locations

Country	Name	City	State
France	Department of Digestive Surgery, Hôpital Saint-Antoine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival and Recurrence free survival after resection of the colon cancer	3 years for prospective patients, more for retrospective patients	End of follow up : at least 3 years	No
Secondary	Overall survival	3 years for prospective patients, more for retrospective patients	End of follow up : at least 3 years	No