Clinical trial NCT04223102: Microbiome and Rectal Cancer
Official title: Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Locally Advanced Malignant Neoplasm
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy
timeFrame: 5 years
Secondary outcomes:
measure: rectal microbiota to study bacteria strains
timeFrame: 5 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida - South Tampa Campus
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: James R Williams, MD
role: PRINCIPAL_INVESTIGATOR
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