Gastrointestinal Microbiome Study of Appendiceal Cancer

Mercy

Status: Enrolling

Conditions: Cancer, Appendiceal; Appendiceal Neoplasm; Pseudomyxoma Peritonei

Treatments: Other: Bio-specimen collection; Other: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02599116

MMC 2015-53

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Microbiome cohort

Other group

Description:

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

Treatment:

Other: Bio-specimen collection

Other: Questionnaire