A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
Status: Unknown
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Mercy Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Mary Caitlin King
mking5@mdmercy.com
410-332-9294
Time Frame
Start Date: 2015-12
Completion Date: 2024-12
Participants
Target number of participants: 24
Treatments
Other: Microbiome cohort
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
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego
Leads: Mercy Medical Center