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ACTIVE NOT RECRUITING
NCT04223102
NA

Microbiome and Rectal Cancer

Sponsor: University of South Florida

View on ClinicalTrials.gov

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.

Official title: Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-02-18

Completion Date

2027-06

Last Updated

2023-08-02

Healthy Volunteers

No

Interventions

PROCEDURE

Tissue collection

A flexible sigmoidoscopy is a procedure in which a flexible tubularized camera approximately 1 cm in diameter is inserted into the anus and advanced proximally to the sigmoid colon (approximately 20 cm). At that time a rectal biopsy of the tumor will be obtained as well as a sample from \>5cm proximal to the tumor, with a separate biopsy forcep. Tattoo injection, as standard of care, will be performed within 1 cm distal to the tumor to identify the location in the future or for surgical intervention. If there is inability to get proximal to the tumor then a location at least 5 cm adjacent in any direction will be sufficient so long as it is grossly normal appearing.

Locations (3)

Tampa General Hospital

Tampa, Florida, United States

University of South Florida - South Tampa Campus

Tampa, Florida, United States

University of South Florida

Tampa, Florida, United States