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Gastrointestinal Microbiome Study of Appendiceal Cancer

Primary Purpose

Pseudomyxoma Peritonei, Appendiceal Neoplasm, Cancer, Appendiceal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bio-specimen collection
Questionnaire
Sponsored by
Mercy Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pseudomyxoma Peritonei focused on measuring cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, microbiome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Microbiome cohort

Arm Description

Pre-operative (baseline) bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires. 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 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

Outcomes

Primary Outcome Measures

Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
Appendiceal cohort to healthy age-matched cohort

Secondary Outcome Measures

Compare the gut microbiome of appendiceal tumors by histopathology
Low-grade and high-grade tumors

Full Information

First Posted
November 4, 2015
Last Updated
March 24, 2023
Sponsor
Mercy Medical Center
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02599116
Brief Title
Gastrointestinal Microbiome Study of Appendiceal Cancer
Official Title
A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Medical Center
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomyxoma Peritonei, Appendiceal Neoplasm, Cancer, Appendiceal
Keywords
cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, microbiome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microbiome cohort
Arm Type
Other
Arm Description
Pre-operative (baseline) bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires. 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 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
Intervention Type
Other
Intervention Name(s)
Bio-specimen collection
Intervention Description
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
Primary Outcome Measure Information:
Title
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
Description
Appendiceal cohort to healthy age-matched cohort
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Compare the gut microbiome of appendiceal tumors by histopathology
Description
Low-grade and high-grade tumors
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Identify potential biomarkers associated with appendiceal tumors
Description
Molecular profile
Time Frame
36 months
Title
Identify alterations in the gut microbiome post-CRS/HIPEC
Description
Compare pre-HIPEC and post-HIPEC samples
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Caitlin King
Phone
410-332-9294
Email
mking5@mdmercy.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Sardi, MD
Organizational Affiliation
Mercy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23844722
Citation
Gilbreath JJ, Semino-Mora C, Friedline CJ, Liu H, Bodi KL, McAvoy TJ, Francis J, Nieroda C, Sardi A, Dubois A, Lazinski DW, Camilli A, Testerman TL, Merrell DS. A core microbiome associated with the peritoneal tumors of pseudomyxoma peritonei. Orphanet J Rare Dis. 2013 Jul 12;8:105. doi: 10.1186/1750-1172-8-105.
Results Reference
result
Links:
URL
http://americangut.org/
Description
The American Gut Project is an open-source project to understand the microbial diversity of the human gut.

Learn more about this trial

Gastrointestinal Microbiome Study of Appendiceal Cancer

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