Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastrointestinal Microbiome Study of Appendiceal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02599116
Recruitment Status : Recruiting
First Posted : November 6, 2015
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Armando Sardi, Mercy Medical Center

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 6, 2015
Last Update Posted Date October 30, 2019
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
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 ]
Appendiceal cohort to healthy age-matched cohort
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
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 ]
Change History Complete list of historical versions of study NCT02599116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
Compare the gut microbiome of appendiceal tumors by histopathology [ Time Frame: 36 months ]
Low-grade and high-grade tumors
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
Compare the gut microbiome of appendiceal tumors by histopathology [ Time Frame: 36 months ]
Current Other Pre-specified Outcome Measures
 (submitted: October 2, 2018)
  • Identify potential biomarkers associated with appendiceal tumors [ Time Frame: 36 months ]
    Molecular profile
  • Identify alterations in the gut microbiome post-CRS/HIPEC [ Time Frame: 36 months ]
    Compare pre-HIPEC and post-HIPEC samples
Original Other Pre-specified Outcome Measures
 (submitted: November 4, 2015)
  • Identify potential biomarkers associated with appendiceal tumors [ Time Frame: 36 months ]
  • Identify alterations in the gut microbiome post-CRS/HIPEC [ Time Frame: 36 months ]
 
Descriptive Information
Brief Title  ICMJE Gastrointestinal Microbiome Study of Appendiceal Cancer
Official Title  ICMJE A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Pseudomyxoma Peritonei
  • Appendiceal Neoplasm
  • Cancer, Appendiceal
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Other: Bio-specimen collection
  • Other: Questionnaire
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Sittig, RN 410-332-9294 msittig@mdmercy.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02599116
Other Study ID Numbers  ICMJE MMC 2015-53
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Armando Sardi, Mercy Medical Center
Study Sponsor  ICMJE Mercy Medical Center
Collaborators  ICMJE University of California, San Diego
Investigators  ICMJE
Principal Investigator: Armando Sardi, MD Mercy Medical Center
PRS Account Mercy Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP