Pseudomyxoma Peritonei, Appendiceal Neoplasm, Cancer, Appendiceal
Conditions
Keywords
cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, microbiome
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.
Interventions
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
OTHERQuestionnaire
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
Sponsors
University of California, San Diego
Mercy Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Compare the gut microbiome of appendiceal tumors by histopathology | 36 months | Low-grade and high-grade tumors |
Other
| Measure | Time frame | Description |
|---|---|---|
| Identify potential biomarkers associated with appendiceal tumors | 36 months | Molecular profile |
| Identify alterations in the gut microbiome post-CRS/HIPEC | 36 months | Compare pre-HIPEC and post-HIPEC samples |
Countries
United States
Contacts
Primary ContactMary Caitlin King
Outcome results
None listed