Clinical trial NCT04006951: Development of a Clinical and Biological Database in Rectum Cancer
Official title: Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Cancer
Colorectal cancer
Biological Specimen Banks
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Proportion of patients who gave their consent to participate in the study
timeFrame: Until the study completion : 66 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM Val d'Aurelle
Study officials:
affiliation: Institut régional du Cancer Montpellier
name: ROUANET Philippe, MD-PhD
role: STUDY_CHAIR
References:
citation: Haustermans K, Debucquoy A, Lambrecht M. The ESTRO Breur Lecture 2010: toward a tailored patient approach in rectal cancer. Radiother Oncol. 2011 Jul;100(1):15-21. doi: 10.1016/j.radonc.2011.05.024. Epub 2011 May 31.