Gastrointestinal Microbiome Study of Appendiceal Cancer

Pseudomyxoma Peritonei Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02599116
• Other study ID #: MMC 2015-53
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Mercy Medical Center
• Contact: Mary Caitlin King
• Phone: 410-332-9294
• Email: mking5[@]mdmercy.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendiceal Neoplasm
• Appendiceal Neoplasms
• Cancer, Appendiceal
• Pseudomyxoma Peritonei

Intervention

Other:
• Bio-specimen collection
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
• Questionnaire
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Mercy Medical Center	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify potential biomarkers associated with appendiceal tumors	Molecular profile	36 months
Other	Identify alterations in the gut microbiome post-CRS/HIPEC	Compare pre-HIPEC and post-HIPEC samples	36 months
Primary	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	36 months
Secondary	Compare the gut microbiome of appendiceal tumors by histopathology	Low-grade and high-grade tumors	36 months

External Links

•   The American Gut Project is an open-source project to understand the microbial diversity of the human gut.