Thoracic Specimen Registry | NCT04118660

Studies
Thoracic Specimen Registry

NCT04118660

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

7,000Estimated

Phase

Not provided

Conditions

Thoracic Diseases
Lung Cancer
Lung Transplant

Interventions

Tissue Banking

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Jan 7, 2019

First Submission Date that Met QC Criteria

Oct 4, 2019

First Posted Date

Oct 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

50 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

7,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue Banking	Other	Blood, tissue, and fluid collection	Thoracic Disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thoracic Specimen Repository	Number of thoracic specimens collected	Through study completion, approximately 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mayo Clinic Rochester patients with thoracic disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aaron Bungum	Contact	507-266-0078		Bungum.Aaron@mayo.edu
Karlyn Pierson, RN	Contact	507-538-1960		pierson.karlyn@mayo.edu

Overall Officials

Name	Affiliation	Role
Eric Edell, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013896	Thoracic Diseases
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014015	Tissue Banks

Ancestor Terms

ID	Term
D018070	Biological Specimen Banks
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.