Thoracic Specimen Registry

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04118660
Collaborator
(none)
7,000
1
94.1
74.4

Study Details

Study Description

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 and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases.

Condition or Disease Intervention/Treatment Phase
  • 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 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
7000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Thoracic Specimen Registry
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Thoracic Specimen Repository [Through study completion, approximately 10 years]

    Number of thoracic specimens collected

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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: Eric Edell, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eric S. Edell, Prinicpal, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04118660
Other Study ID Numbers:
  • 16-009655
First Posted:
Oct 8, 2019
Last Update Posted:
Nov 10, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Nov 10, 2021