Rectal Cancer Clinical Trial
Official title:
Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence
Verified date | July 2023 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | June 2027 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Tampa General Hospital | Tampa | Florida |
United States | University of South Florida | Tampa | Florida |
United States | University of South Florida - South Tampa Campus | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida |
United States,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy | 16s rRNA sequencing from biopsy specimens | 5 years | |
Secondary | rectal microbiota to study bacteria strains | rectal microbiota - bacteria strains from biopsy specimens | 5 years |
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