Development of a Clinical and Biological Database in Rectum Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological collection.
- Who it may be relevant to
- Registry conditions: Rectal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
Overview
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.
Interventions
- Other Biological collection
Blood samples are collected at different times : * Before any treatment * After pre-operative radiochemotherapy and before surgery (if applicable)
Primary outcome measures
- Proportion of patients who gave their consent to participate in the study [Time frame: Until the study completion : 66 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- ICM Val d'Aurelle — Montpellier
Publications
- 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. PMID 21632132
Identifiers
NCT: NCT04006951 · ICM-BCB-2014/02