Development of a Clinical and Biological Database in Rectum Cancer
Rectal Neoplasms
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 300 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Biological collection
For all the patients include in the study :
- Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy
- Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy
In parallel to this biological collection, standardized clinical data will be entered into a database
Other: Biological collection
Biological collection OTHER
Blood samples are collected at different times :
- Before any treatment
- After pre-operative radiochemotherapy and before surgery (if applicable)
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
ICM Val d'AurelleMontpellier, Montpellier, FranceStatus unknown
Study team and timeline
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Study start
- Oct 8, 2014 Actual
- Primary completion
- 2026-07 Actual
- Study completion
- 2026-12 Estimated
- First posted
- Jul 5, 2019 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026