Microbiome and Rectal Cancer

NCT04223102 | Active Not Recruiting

• 1 other identifier: Pro00040924
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Rectal Cancer; Locally Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy

  16s rRNA sequencing from biopsy specimens

  5 years

Secondary Outcomes (1)

• rectal microbiota to study bacteria strains

  5 years

Study Arms (1)

Tissue collection

OTHER

Tissue collection

Procedure: Tissue collection

Interventions

Tissue collection PROCEDURE

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.

Tissue collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (3)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (35)

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MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Tissue Banks

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• James R Williams, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: January 10, 2020
• Study Start: February 18, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)