NCT02599116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

9 years

First QC Date

November 4, 2015

Last Update Submit

March 24, 2023

Conditions

Pseudomyxoma PeritoneiAppendiceal NeoplasmCancer, Appendiceal

Keywords

cytoreductive surgeryhyperthermic intraperitoneal chemotherapymicrobiome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Compare the gut microbiome of appendiceal tumors by histopathology

    36 months

Other Outcomes (2)

  • Identify potential biomarkers associated with appendiceal tumors

    36 months

  • Identify alterations in the gut microbiome post-CRS/HIPEC

    36 months

Study Arms (1)

Microbiome cohort

OTHER

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 collectionOther: Questionnaire

Interventions

Bio-specimen collectionOTHER

Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections

Microbiome cohort
QuestionnaireOTHER

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

Microbiome cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<18 years of age
  • Pregnant women
  • Concurrent severe medical problems unrelated to malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23844722RESULT

Related Links

MeSH Terms

Conditions

Pseudomyxoma PeritoneiAppendiceal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Adenocarcinoma, MucinousAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and SerousCecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Armando Sardi, MD

    Mercy Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Caitlin King

CONTACT

410-332-9294mking5@mdmercy.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Surgical Oncology at Mercy

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 6, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)