NCT02648763

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

January 15, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2023

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

7.3 years

First QC Date

November 20, 2015

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of surgical staging versus imaging procedures based on surgical findings.

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

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving treatment at the Mayo Clinic Rochester 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subject is \<18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

MesotheliomaSolitary Fibrous Tumor, Pleural

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialSolitary Fibrous TumorsNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissuePleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Officials

  • Dennis Wigle, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2015

First Posted

January 7, 2016

Study Start

January 15, 2016

Primary Completion

April 22, 2023

Study Completion

April 22, 2023

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations