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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

16s rRNA gene sequencing to study bacterial phylogeny and taxonomy

Secondary outcome measures

rectal microbiota to study bacteria strains

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tissue collectionExperimental Treatment1 Intervention

Tissue collection

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor

413 Previous Clinical Trials

188,227 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for participants in this experiment?

"Affirmative. Per the clinicaltrials.gov entry, this particular medical trial is still open for recruitment and was initially published on February 18th 2020 with its last modification made on September 28th 2021. Forty patients are needed from two sites to complete the study."

Answered by AI

How many volunteers are being monitored as part of this research project?

"Indeed, the website clinicaltrials.gov confirms that this medical trial is still looking for subjects; it was first released on February 18th 2020 and its most recent update occurred on September 28th 2021. The study seeks to enrol 40 patients from 2 distinct sites."

Answered by AI

Recent research and studies

Genome ResearchJournal

The NIH Human Microbiome Project

The NIH HMP Working Group, Jane Peterson, Susan Garges, Maria Giovanni, Pamela McInnes, Lu Wang, Jeffery A. Schloss, et al.. 2009. “The NIH Human Microbiome Project”. Genome Research. Cold Spring Harbor Laboratory. doi:10.1101/gr.096651.109.

GastroenterologyJournal

Association Between Bacteremia from Specific Microbes and Subsequent Diagnosis of Colorectal Cancer

Kwong, Thomas N.Y., Xiansong Wang, Geicho Nakatsu, Tai Cheong Chow, Timothy Tipoe, Rudin Z.W. Dai, Kelvin K.K. Tsoi, et al.. 2018. “Association Between Bacteremia from Specific Microbes and Subsequent Diagnosis of Colorectal Cancer”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2018.04.028.

PLoS ONEJournal

Human Intestinal Lumen and Mucosa-associated Microbiota in Patients with Colorectal Cancer

Chen, Weiguang, Fanlong Liu, Zongxin Ling, Xiaojuan Tong, and Charlie Xiang. 2012. “Human Intestinal Lumen and Mucosa-associated Microbiota in Patients with Colorectal Cancer”. Edited by Antonio Moschetta. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0039743.

Clinics in Colon and Rectal SurgeryJournal