Rectal Cancer, Locally Advanced Malignant Neoplasm
Conditions
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.
Interventions
PROCEDURETissue collection
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.
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy | 5 years | 16s rRNA sequencing from biopsy specimens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rectal microbiota to study bacteria strains | 5 years | rectal microbiota - bacteria strains from biopsy specimens |
Countries
United States
Outcome results
None listed