Microbiome Analysis for Rectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the link between gut bacteria and treatment response in individuals with rectal adenocarcinoma (a type of cancer in the rectum) before surgery. Researchers collect tissue samples to determine if certain microbiomes (the community of bacteria living in the body) correlate with better or worse treatment responses. Suitable participants have locally advanced rectal adenocarcinoma and are undergoing a specific type of chemotherapy and radiation. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future cancer treatments.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since it involves standard chemoradiation, you might need to continue with those treatments.
What prior data suggests that tissue collection is safe?
This study does not test a new treatment. Instead, researchers examine tissue samples by collecting small pieces to learn more about rectal cancer. Since this is not a drug or new therapy, typical safety concerns like side effects are not an issue. Tissue collection is a common part of medical research and is generally considered safe. Participants might experience some discomfort during sample collection, but it is usually a low-risk process.
Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on analyzing the microbiome in rectal cancer through tissue collection. Unlike standard treatments that primarily involve surgery, chemotherapy, and radiation, this approach investigates the role of microorganisms living in the body and their impact on cancer development and progression. By understanding these microbial influences, scientists hope to uncover new insights that could lead to more personalized and effective treatments for rectal cancer in the future.
What evidence suggests that this trial's method could be effective for rectal cancer?
Research has shown that the microbiome, the collection of bacteria and other tiny organisms in the body, might influence how well people respond to cancer treatments. Studies have found that differences in the microbiome can impact the success of neoadjuvant therapy, which is given before the main treatment to shrink a tumor. Some research suggests that certain types of gut bacteria might improve responses to rectal cancer treatment. In this trial, participants will undergo tissue collection to help researchers discover any connection between these bacteria and treatment response. This could lead to more personalized and effective cancer treatments in the future.
Who Is on the Research Team?
James R Williams, MD
Principal Investigator
University of South Florida
Are You a Good Fit for This Trial?
This trial is for adults over 18 with locally advanced rectal adenocarcinoma (T3) who are following the OPRA protocol for neoadjuvant therapy. It's not open to those under 18, with stage I or IV cancer, non-adenocarcinoma rectal cancers, a history of this cancer type, or genetically linked cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Tissue Collection
Collection of tissue samples for microbiome analysis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tissue collection
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor