Gastrointestinal Microbiome Study of Appendiceal Cancer

Not Applicable

Recruiting

• Conditions: Pseudomyxoma Peritonei; Appendiceal Neoplasm; Cancer, Appendiceal
• Interventions: Other: Bio-specimen collection; Other: Questionnaire

• Registration Number: NCT02599116
• Lead Sponsor: Mercy Medical Center

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.

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Study Start: 2015-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microbiome cohort	Bio-specimen collection	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
Microbiome cohort	Questionnaire	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

Primary Outcome Measures

Name	Time	Method
Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort	36 months	Appendiceal cohort to healthy age-matched cohort

Secondary Outcome Measures

Name	Time	Method
Compare the gut microbiome of appendiceal tumors by histopathology	36 months	Low-grade and high-grade tumors

Trial Locations

Locations (1)

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States