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Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this project is to determine in a non-invasive manner (fecal samples) the predictive value of the intestinal microbiota and the presence of genotoxin-producing bacteria on the response to neoadjuvant treatment in rectal cancer. This could lead to a better understanding and selection of patients for personalized treatment in rectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III

• Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed

• Patient who has signed the informed consent of the study

• Male or female ≥ 18 years old

• Appropriate contraceptive measures should be used by both men and non-menopausal women before entering the trial until at least 8 weeks after the last course of radiochemotherapy. The investigator should inform the patient about the contraceptive measures to be used.

Locations
Other Locations
France
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Institut régional du Cancer de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Aurore MOUSSION, MD
Aurore.Moussion@icm.unicancer.fr
0467612446
Time Frame
Start Date: 2020-01-14
Estimated Completion Date: 2030-01-30
Participants
Target number of participants: 220
Treatments
Experimental: Biological collection
Fecal samples collected at different times : During inclusion consultation with surgeon, after neoadjuvant treatment and before surgery,~In parallel to this fecal collection, standardized clinical data will be entered into a database
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov