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New treatment option for Rectal Cancer
Official title Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
ClinicalTrials.gov ID: NCT04103567
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Antibiotic treatment at the time or in the month preceding stool sampling
- Presence of an ostomy
- Previous treatment for rectal cancer
- Patient not affiliated to a French social protection system
- Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons
- Legal incapacity (Patient under curatorship or guardianship)
See the full eligibility criteria
- 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...
- Antibiotic treatment at the time or in the month preceding stool sampling
- Presence of an ostomy
- Previous treatment for rectal cancer
- Patient not affiliated to a French social protection system
- Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons
- Legal incapacity (Patient under curatorship or guardianship)
- Prior radiation therapy or pelvic curia in the year prior to inclusion
- History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally)
- Pregnant or breastfeeding woman
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, Hérault, France
- Clermont-Ferrand, Puy De Dôme, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, Hérault, France; Clermont-Ferrand, Puy De Dôme, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.