Gastrointestinal Microbiome Study of Appendiceal Cancer

March 24, 2023 updated by: Armando Sardi, Mercy Medical Center

A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread

This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Analysis of the human microbiome is an attempt to define how changes in the human microbiome are associated with health or disease.

Eligible participants scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal cancer will provide fecal samples pre- and post-operatively. Investigators will analyze potential changes in the gastrointestinal microbiome and make comparisons to an age-matched healthy sample.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of appendiceal cancer with peritoneal spread
  • Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)
  • ≥18 and ≤ 80 years of age
  • Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%
  • Signed Institutional Review Board approved informed consent

Exclusion Criteria:

  • <18 years of age
  • Pregnant women
  • Concurrent severe medical problems unrelated to malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Microbiome cohort
  1. Pre-operative (baseline) bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires.
  2. Six to twelve weeks following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), post-operative bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires
  3. Six to twelve months following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), post-operative bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires
Other: Bio-specimen collection
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
Other: Questionnaire
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
Time Frame: 36 months
Appendiceal cohort to healthy age-matched cohort
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the gut microbiome of appendiceal tumors by histopathology
Time Frame: 36 months
Low-grade and high-grade tumors
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify potential biomarkers associated with appendiceal tumors
Time Frame: 36 months
Molecular profile
36 months
Identify alterations in the gut microbiome post-CRS/HIPEC
Time Frame: 36 months
Compare pre-HIPEC and post-HIPEC samples
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Medical Center

Collaborators

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC 2015-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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