Microbiome and Rectal Cancer

  • STATUS
    Recruiting
  • End date
    Jun 28, 2027
  • participants needed
    40
  • sponsor
    University of South Florida
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Updated on 16 February 2024
See if I qualify
cancer
adenocarcinoma
chemoradiotherapy
adjuvant therapy
rectal carcinoma
rectal cancer
adenocarcinoma of rectum
neoadjuvant therapy

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.

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.

Details
Condition Colorectal Cancer, Colorectal Cancer, Rectal Cancer, Rectal Cancer, Locally Advanced Malignant Neoplasm
Age 18years - 100years
Treatment Tissue collection
Clinical Study IdentifierNCT04223102
SponsorUniversity of South Florida
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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)
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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