Microbiome and Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer, Locally Advanced Malignant Neoplasm

Intervention / Treatment
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* Procedure: Tissue collection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tissue collection<br>Tissue collection | Procedure: Tissue collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy | 16s rRNA sequencing from biopsy specimens | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rectal microbiota to study bacteria strains | rectal microbiota - bacteria strains from biopsy specimens | 5 years |