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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microbiome cohort | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-specimen collection | Other | Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the gut microbiome of appendiceal tumors by histopathology | Low-grade and high-grade tumors | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identify potential biomarkers associated with appendiceal tumors | Molecular profile | 36 months |
| Identify alterations in the gut microbiome post-CRS/HIPEC | Compare pre-HIPEC and post-HIPEC samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Caitlin King | Contact | 410-332-9294 | mking5@mdmercy.com |
| Name | Affiliation | Role |
|---|---|---|
| Armando Sardi, MD | Mercy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Medical Center | Recruiting | Baltimore | Maryland | 21202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23844722 | Result | 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. |
| Label | URL |
|---|---|
| The American Gut Project is an open-source project to understand the microbial diversity of the human gut. | View source |
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| ID | Term |
|---|---|
| D011553 | Pseudomyxoma Peritonei |
| D001063 | Appendiceal Neoplasms |
| ID | Term |
|---|---|
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaire | Other | Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint |
|
| 36 months |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |