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Thoracic Specimen Registry

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ClinicalTrials.gov Identifier: NCT04118660
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Eric S. Edell, Mayo Clinic

Study Description
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Brief Summary:
The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors, lung transplants and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases.

Condition or disease Intervention/treatment
Thoracic Diseases Lung Cancer Lung Transplant Other: Tissue Banking

Detailed Description:
The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors, lung transplants and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. Collected specimens will include peripheral blood, bronchoalveolar lavage (BAL) fluid, pleural fluid, tissue (surgical resections & biopsies) and touch prep samples. The specimens will be stored in a central location at Mayo Clinic and managed by the Mayo Clinic Thoracic Specimen Registry Steering Committee. The registry will be a foundation for the development and implementation of research protocols and clinical trials that will enhance current knowledge of etiology and detection, discovery of new molecular and biochemical markers for screening, early diagnosis, and develop state-of-the-art therapeutic and preventive interventions for managing patients with, or at risk for, thoracic cancers or other thoracic diseases.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 50 Years
Official Title: Thoracic Specimen Registry
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Thoracic Disease
Thoracic Diseases (which includes but not limited to the following: thoracic neoplasms (masses/nodules) malignant or benign, interstitial lung diseases (ILD), chronic obstructive pulmonary disease (COPD), thoracic infections, thoracic malignancies metastatic to other organs, other cancers metastatic to the thoracic cavity.
 Other: Tissue Banking
Blood, tissue, and fluid collection


Outcome Measures
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Primary Outcome Measures :
  1. Thoracic Specimen Repository [ Time Frame: Through study completion, approximately 10 years ]
    Number of thoracic specimens collected


Biospecimen Retention:   Samples With DNA

A blood sample will be collected at the time of consent/baseline. Optional subsequent blood draws maybe requested no more frequently than every 8 weeks. Patients scheduled for their clinically indicated thoracic procedure and have excess of clinical diagnostic tissue available will have tissue kept in the registry for future research. Patients scheduled for their clinical indicated bronchoscopy or CT guided procedure may have a sample go through the Touch Prep process and slides/cells will be kept for future research.

Patients scheduled for clinically indicated bronchoscopy with bronchoalveolar lavage BAL or Thoracentesis (TAP) procedure as part of that procedure may have fluid that is in excess of clinical diagnostic material, saved of future research. In addition, at the time of any future clinically indicated blood draws, thoracic procedures, thoracic resections, or metastatic thoracic primary tumors resections from other organs tissue will be requested for the research study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic Rochester patients with thoracic disease
Criteria

Inclusion Criteria:

  • Subject must be > 18 years of age
  • Presumed or known or screening of Thoracic Diseases (which includes but not limited to the following: thoracic neoplasms (masses/nodules) malignant or benign, interstitial lung diseases (ILD), chronic obstructive pulmonary disease (COPD), thoracic infections, thoracic malignancies metastatic to other organs, other cancers metastatic to the thoracic cavity.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118660


Contacts
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Contact: Aaron Bungum 507-266-0078 Bungum.Aaron@mayo.edu
Contact: Karlyn Pierson, RN 507-538-1960 pierson.karlyn@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Aaron Bungum    507-266-0078    Bungum.Aaron@mayo.edu   
Principal Investigator: Eric Edell, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Eric Edell, MD Mayo Clinic
More Information
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Responsible Party: Eric S. Edell, Prinicpal, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04118660    
Other Study ID Numbers: 16-009655
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thoracic Diseases
Respiratory Tract Diseases