Microbiome and Rectal Cancer

University of South Florida

Status: Active, not recruiting

Conditions: Locally Advanced Malignant Neoplasm; Rectal Cancer

Treatments: Procedure: Tissue collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04223102

Pro00040924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Tissue collection

Other group

Description:

Tissue collection

Treatment:

Procedure: Tissue collection