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OpenTrials
Active, Not Recruiting

NCT Number: NCT04223102

Microbiome and Rectal Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Locally Advanced Malignant Neoplasm Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tissue collection

Procedure

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.

Primary outcomes

  1. 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy

    Time frame: 5 years

    16s rRNA sequencing from biopsy specimens

Secondary outcomes

  1. rectal microbiota to study bacteria strains

    Time frame: 5 years

    rectal microbiota - bacteria strains from biopsy specimens

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2020
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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