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Microbiome Analysis for Rectal Cancer

N/A
Waitlist Available
Led By James R Williams, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Standard 5FU based chemoradiation
Must not have
Rectal cancer other than adenocarcinoma
Stage I or Stage IV rectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the microbiome (bacteria in the gut) is different in people with rectal cancer who respond well to treatment versus those who don't.

Who is the study for?
This trial is for adults over 18 with locally advanced rectal adenocarcinoma (T3) who are following the OPRA protocol for neoadjuvant therapy. It's not open to those under 18, with stage I or IV cancer, non-adenocarcinoma rectal cancers, a history of this cancer type, or genetically linked cancers.
What is being tested?
The study aims to see if there's a link between the microbiome and how well patients respond to pre-surgery treatment for rectal adenocarcinoma. Researchers will collect tissue samples from participants to analyze this potential association.
What are the potential side effects?
Since the intervention involves tissue collection rather than drug administration, typical medication side effects aren't expected. However, minor risks may include discomfort or complications at the biopsy site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am receiving or have received 5FU-based chemoradiation.
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My condition is stage T3 rectal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My rectal cancer is not adenocarcinoma.
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My condition is either early (Stage I) or advanced (Stage IV) rectal cancer.
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My cancer is linked to a genetic condition like HNPCC or FAP.
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I am under 18 years old.
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I have had rectal cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
16s rRNA gene sequencing to study bacterial phylogeny and taxonomy
Secondary study objectives
rectal microbiota to study bacteria strains

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tissue collectionExperimental Treatment1 Intervention
Tissue collection

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
426 Previous Clinical Trials
192,029 Total Patients Enrolled
James R Williams, MDPrincipal InvestigatorUniversity of South Florida

Media Library

Tissue collection Clinical Trial Eligibility Overview. Trial Name: NCT04223102 — N/A
Colorectal Cancer Research Study Groups: Tissue collection
Colorectal Cancer Clinical Trial 2023: Tissue collection Highlights & Side Effects. Trial Name: NCT04223102 — N/A
Tissue collection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04223102 — N/A
~12 spots leftby Jan 2027
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