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Trial record 6 of 19 for:    "Pseudomyxoma peritonei"

Gastrointestinal Microbiome Study of Appendiceal Cancer

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ClinicalTrials.gov Identifier: NCT02599116
Recruitment Status : Recruiting
First Posted : November 6, 2015
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Armando Sardi, Mercy Medical Center

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.

Condition or disease Intervention/treatment Phase
Pseudomyxoma Peritonei Appendiceal Neoplasm Cancer, Appendiceal Other: Bio-specimen collection Other: Questionnaire Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other: Bio-specimen collection
Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections

Other: Questionnaire
Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint




Primary Outcome Measures :
  1. Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Compare the gut microbiome of appendiceal tumors by histopathology [ Time Frame: 36 months ]

Other Outcome Measures:
  1. Identify potential biomarkers associated with appendiceal tumors [ Time Frame: 36 months ]
  2. Identify alterations in the gut microbiome post-CRS/HIPEC [ Time Frame: 36 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599116


Contacts
Contact: Michelle Sittig, RN 410-332-9294 msittig@mdmercy.com

Locations
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Mercy Medical Center
University of California, San Diego
Investigators
Principal Investigator: Armando Sardi, MD Mercy Medical Center

Additional Information:
Publications of Results:
Responsible Party: Armando Sardi, Chief Surgical Oncology at Mercy, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT02599116     History of Changes
Other Study ID Numbers: MMC 2015-53
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Armando Sardi, Mercy Medical Center:
cytoreductive surgery
hyperthermic intraperitoneal chemotherapy
microbiome

Additional relevant MeSH terms:
Pseudomyxoma Peritonei
Appendiceal Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cecal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases