Gastrointestinal Microbiome Study of Appendiceal Cancer
NCT ID: NCT02599116
Last Updated: 2023-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2015-12-31
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
Bio-specimen collection
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
Questionnaire
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
Interventions
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Bio-specimen collection
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
Questionnaire
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women
* Concurrent severe medical problems unrelated to malignancy
18 Years
80 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Mercy Medical Center
OTHER
Responsible Party
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Armando Sardi
Chief Surgical Oncology at Mercy
Principal Investigators
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Armando Sardi, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy Medical Center
Locations
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Mercy Medical Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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References
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Gilbreath JJ, Semino-Mora C, Friedline CJ, Liu H, Bodi KL, McAvoy TJ, Francis J, Nieroda C, Sardi A, Dubois A, Lazinski DW, Camilli A, Testerman TL, Merrell DS. A core microbiome associated with the peritoneal tumors of pseudomyxoma peritonei. Orphanet J Rare Dis. 2013 Jul 12;8:105. doi: 10.1186/1750-1172-8-105.
Related Links
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The American Gut Project is an open-source project to understand the microbial diversity of the human gut.
Other Identifiers
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MMC 2015-53
Identifier Type: -
Identifier Source: org_study_id
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