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NCT04223102Active, not recruiting

Microbiome and Rectal Cancer

Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence

Source: ClinicalTrials.gov · Last updated 2 Aug 2023

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
12 Nov 2019
Start date
Feb 2020
Primary completion date
Jan 2027
Lead sponsor
University of South Florida
NCT number
NCT04223102

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From Feb 2020 to the primary completion date, Jan 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior history of rectal adenocarcinoma (i.e. recurrent colorectal adenocarcinoma)

Other illness

  • Rectal cancer other than adenocarcinoma
  • Genetically associated cancer (HNPCC, FAP etc.) or highly suspicious for genetically associated cancer

Age

  • Age \< 18 years

Other

  • Stage I or Stage IV rectal adenocarcinoma

Who the study is looking for

  • Age ≥ 18 years old
  • Locally Advanced Rectal Adenocarcinoma (T3)
  • Standard 5FU based chemoradiation
  • Total Neoadjuvant Therapy per OPRA protocol guidelines

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of South Florida
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Tampa General Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
University of South Florida - South Tampa Campus
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.