Recruiting

Microbiome Study

Sponsor:

Mercy Medical Center

Code:

NCT02599116

Conditions

Pseudomyxoma Peritonei

Appendiceal Neoplasm

Cancer, Appendiceal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bio-specimen collection

Questionnaire

Study Details

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.

Conditions

Pseudomyxoma Peritonei

Appendiceal Neoplasm

Cancer, Appendiceal

Study ID

NCT02599116

Start date

Dec, 2015

Status verified date

Mar, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Mary Caitlin King

410-332-9294mking5@mdmercy.com

Locations

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

More Information

Sponsor

Mercy Medical Center

Last update posted

Mar 27, 2023

Last verified

Mar, 2023

Keywords

  • cytoreductive surgery
  • hyperthermic intraperitoneal chemotherapy
  • microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Medical Center on 2023-03-27.