Staging Procedures to Diagnose Malignant Pleural Mesothelioma

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02648763
Collaborator
(none)
200
1
80.6
2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the accuracy of participants imaging versus staging procedures. The investigators will consent subjects that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Staging Procedures to Diagnose Malignant Pleural Mesothelioma
    Actual Study Start Date :
    Mar 14, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of surgical staging versus imaging procedures based on surgical findings. [2 years]

      The staging imaging will be compared with the actual surgical staging procedure to evaluate the accuracy of the imaging.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject provides informed consent

    • Subject is >18 years of age

    • Subject is deemed competent for making medical decisions

    • Subject is scheduled to undergo a staging pleuroscopy

    • Subject is a surgical candidate

    • A negative pregnancy test is required in women of child-bearing potential, as standard of care.

    Exclusion Criteria:
    • Subject is <18 years old.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Dennis Wigle, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Dennis Wigle, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02648763
    Other Study ID Numbers:
    • 15-007647
    First Posted:
    Jan 7, 2016
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 17, 2021