An interventional study of Bio-specimen collection and Questionnaire in Pseudomyxoma Peritonei, Appendiceal Neoplasm and Cancer, Appendiceal, sponsored by Mercy Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Mercy Medical Center · Not applicable, Interventional, and Other
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.
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.
35 studies on the registry are indexed under Pseudomyxoma Peritonei; 14 are open to participants now.
This study's planned enrollment of 24 is below the median of 38 across 25 interventional studies indexed under Pseudomyxoma Peritonei.
Browse Pseudomyxoma Peritonei studies →Mercy Medical Center is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Bio-specimen collection · Other: Questionnaire
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
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
Time frame: 36 months
Compare the gut microbiome of appendiceal tumors by histopathology
Low-grade and high-grade tumors
Time frame: 36 months
Identify potential biomarkers associated with appendiceal tumors
Molecular profile
Time frame: 36 months
Identify alterations in the gut microbiome post-CRS/HIPEC
Compare pre-HIPEC and post-HIPEC samples
Time frame: 36 months
Plan to share: No
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Mercy Medical Center