Microbiome and Rectal Cancer

Not Applicable

Active, not recruiting

• Conditions: Rectal Cancer; Locally Advanced Malignant Neoplasm
• Interventions: Procedure: Tissue collection

• Registration Number: NCT04223102
• Lead Sponsor: University of South Florida

Brief Summary

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.

Detailed Description

This study will help to further elucidate the association of bacteria with rectal cancer, while also characterizing the genes associated with that risk. Furthermore it will attempt to better understand which patients may have an optimal response to neoadjuvant chemoradiation allowing for possible predictive metagenomics evaluation, investigators may be able to augment treatments as well as provide recommendations for the success and cost effectiveness of cancer care.

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2020-02-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02
• Primary Completion: 2027-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥ 18 years old
• Locally Advanced Rectal Adenocarcinoma (T3)
• Standard 5FU based chemoradiation
• Total Neoadjuvant Therapy per OPRA protocol guidelines

Read More

Exclusion Criteria

• Age < 18 years
• Stage I or Stage IV rectal adenocarcinoma
• Rectal cancer other than adenocarcinoma
• Genetically associated cancer (HNPCC, FAP etc.) or highly suspicious for genetically associated cancer
• Prior history of rectal adenocarcinoma (i.e. recurrent colorectal adenocarcinoma)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tissue collection	Tissue collection	Tissue collection

Primary Outcome Measures

Name	Time	Method
16s rRNA gene sequencing to study bacterial phylogeny and taxonomy	5 years	16s rRNA sequencing from biopsy specimens

Secondary Outcome Measures

Name	Time	Method
rectal microbiota to study bacteria strains	5 years	rectal microbiota - bacteria strains from biopsy specimens

Trial Locations

Locations (3)

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of South Florida - South Tampa Campus; 🇺🇸 Tampa, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States