Microbiome Analysis for Rectal Cancer

Recruiting at 2 trial locations

Overseen By Beth Montera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must be taking: 5FU chemoradiation

Disqualifiers: Stage I, Stage IV, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of our study is to determine if an association exists between the microbiome of those with rectal adenocarcinoma who are complete pathologic responders and those who have a partial or no response to neoadjuvant therapy.

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 data supports the effectiveness of the treatment Tissue collection for rectal cancer?

Research shows that analyzing the microbiome (the community of microorganisms) in rectal cancer tissue can help understand how patients respond to treatments like chemoradiotherapy. This suggests that studying the microbiome in tissue samples could be useful in predicting treatment outcomes and tailoring therapies for better effectiveness. ^{1 2 3 4 5}

Is microbiome analysis for rectal cancer safe for humans?

The studies reviewed focus on the technical feasibility and microbiome profiling in colorectal cancer, but they do not provide specific safety data for humans. However, microbiome analysis generally involves collecting and analyzing samples, which is considered safe and non-invasive. ^{1 2 3 4 6}

How does the microbiome analysis treatment for rectal cancer differ from other treatments?

This treatment is unique because it focuses on analyzing the gut microbiome (the community of microorganisms in the intestines) to understand its role in rectal cancer and its response to existing therapies, rather than directly targeting the cancer cells themselves. ^{1 2 3 7 8}

Research Team

James R Williams, MD

Principal Investigator

University of South Florida

Eligibility Criteria

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

I am 18 years old or older.

I am following a complete pre-surgery cancer treatment plan.

I am receiving or have received 5FU-based chemoradiation.

Exclusion Criteria

My rectal cancer is not adenocarcinoma.

My condition is either early (Stage I) or advanced (Stage IV) rectal cancer.

My cancer is linked to a genetic condition like HNPCC or FAP.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Collection

Collection of tissue samples for microbiome analysis

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Tissue collection

Trial Overview The study aims to see if there's a link between the microbiome and how well patients respond to pre-surgery treatment for rectal adenocarcinoma. Researchers will collect tissue samples from participants to analyze this potential association.

Participant Groups

Group I: Tissue collection Experimental Treatment 1 Intervention

Tissue collection

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Metagenomic Analysis of Intratumoral Microbiome Linking to Response to Neoadjuvant Chemoradiotherapy in Rectal Cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Assessment of bacterial and viral gut communities in healthy and tumoral colorectal tissue using RNA and DNA deep sequencing. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Microbiome Analysis from Paired Mucosal and Fecal Samples of a Colorectal Cancer Biobank. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective and Cross-sectional Associations of the Rectal Tissue Microbiome with Colorectal Adenoma Recurrence. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Colorectal Tumour Mucosa Microbiome Is Enriched in Oral Pathogens and Defines Three Subtypes That Correlate with Markers of Tumour Progression. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Microbiome Dynamics During Chemoradiation Therapy for Anal Cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Characterization of the consensus mucosal microbiome of colorectal cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Using fecal immmunochemical cartridges for gut microbiome analysis within a colorectal cancer screening program. [2023]