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Trial record 5 of 44 for:    mesothelioma AND Minnesota

Staging Procedures to Diagnose Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT02648763
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Tracking Information
First Submitted Date November 20, 2015
First Posted Date January 7, 2016
Last Update Posted Date September 17, 2021
Actual Study Start Date March 14, 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2016)
Accuracy of surgical staging versus imaging procedures based on surgical findings. [ Time Frame: 2 years ]
The staging imaging will be compared with the actual surgical staging procedure to evaluate the accuracy of the imaging.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Staging Procedures to Diagnose Malignant Pleural Mesothelioma
Official Title Staging Procedures to Diagnose Malignant Pleural Mesothelioma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition
  • Mesothelioma
  • Solitary Fibrous Tumor of the Pleura
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 6, 2016)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karlyn Pierson, RN 507-293-0807 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg, MBA 507-293-0807 lechtenberg.bettie@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02648763
Other Study ID Numbers 15-007647
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dennis Wigle, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2021