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Clinical Trials/NCT04006951
NCT04006951
Recruiting
N/A

Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer

Institut du Cancer de Montpellier - Val d'Aurelle1 site in 1 country300 target enrollmentOctober 8, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rectal Neoplasms
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Enrollment
300
Locations
1
Primary Endpoint
Proportion of patients who gave their consent to participate in the study
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.

Detailed Description

In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers. Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results. Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%. Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy. Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response. Progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community. A clinical and biological collection will allow to : * develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence * optimize diagnostic and follow-up tests * develop new biomarkers to improve patient's therapeutic management In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.

Registry
clinicaltrials.gov
Start Date
October 8, 2014
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
  • Age \> 18 years
  • Signed informed consent

Exclusion Criteria

  • Patient not affiliated to Social Protection system
  • Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  • Patient under guardianship

Outcomes

Primary Outcomes

Proportion of patients who gave their consent to participate in the study

Time Frame: Until the study completion : 66 months

The proportion of patients who consent to participate in the study among the screened patients

Study Sites (1)

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