Clinical trial · Interventional
Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli
NCT04103567CI-TRIAL-00085872MICARErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological collection
- description
- 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
- interventionNames
- Other: Biological collection
Primary outcomes (1)
- measure
- The ratio between the proportions of poor response to neoadjuvant treatment in populations so-called "exposed" (patients colonized by bacteria producing toxins (cyclomodulin) and unexposed (patients not colonized by bacteria producing toxins)
- timeFrame
- About 1 years
Secondary outcomes (12)
- measure
- Change of cyclomodulin-Producing Escherichia Coli colonization rate before and after neoadjuvant treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III 2. Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed 3. Patient who has signed the informed consent of the study 4. Male or female ≥ 18 years old 5. 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. Exclusion Criteria: 1. Antibiotic treatment at the time or in the month preceding stool sampling 2. Presence of an ostomy 3. Previous treatment for rectal cancer 4. Patient not affiliated to a French social protection system 5. Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons 6. Legal incapacity (Patient under curatorship or guardianship) 7. Prior radiation therapy or pelvic curia in the year prior to inclusion 8. History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally) 9. Pregnant or breastfeeding woman
References
Publications (17)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDGerard JP, Andre T, Bibeau F, Conroy T, Legoux JL, Portier G, Bosset JF, Cadiot G, Bouche O, Bedenne L; Societe Francaise de Chirurgie Digestive (SFCD), Societe Francaise d'Endoscopie Digestive (SFED0), Societe Francaise de Radiotherapie Oncologique (SFRO). Rectal cancer: French Intergroup clinical practice guidelines for diagnosis, treatments and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO). Dig Liver Dis. 2017 Apr;49(4):359-367. doi: 10.1016/j.dld.2017.01.152. Epub 2017 Jan 20. PMID 28179091
- BACKGROUNDvan Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17. PMID 21596621
- BACKGROUNDSauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694. PMID 15496622
- BACKGROUNDDworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis. 1997;12(1):19-23. doi: 10.1007/s003840050072. PMID 9112145
- BACKGROUNDHabr-Gama A, Perez RO, Nadalin W, Sabbaga J, Ribeiro U Jr, Silva e Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg. 2004 Oct;240(4):711-7; discussion 717-8. doi: 10.1097/01.sla.0000141194.27992.32.