Gastrointestinal Microbiome Study of Appendiceal Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Pseudomyxoma Peritonei, Appendiceal Neoplasm, Cancer, Appendiceal

Intervention / Treatment
-----------------
* Other: Bio-specimen collection
* Other: Questionnaire


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Microbiome cohort<br>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 | Other: Bio-specimen collection<br>* Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections<br>Other: Questionnaire<br>* Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint<br>|

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 | 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 | Low-grade and high-grade tumors | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, microbiome