Recruiting

Molecular Analysis

Sponsor:

Mayo Clinic

Code:

NCT06482073

Conditions

Lung Carcinoma

Metastatic Malignant Neoplasm in the Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates the effectiveness of tumor samples in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.

Conditions

Lung Carcinoma

Metastatic Malignant Neoplasm in the Lung

Study ID

NCT06482073

Start date

Jun 24, 2024

Status verified date

Sep, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject age 18 years and older
  • Subject is scheduled/was scheduled for a bronchoscopy or surgical resection as part of standard of care
  • Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease
  • Ability to provide blood or saliva sample
  • Ability to provide archived tissue
  • Subject is able to understand and adhere to study requirements and able to provide informed consent

Exclusion Criteria:

  • Individuals who have situations that would limit compliance with the study requirements
  • Institutionalized (i.e. federal medical prison)
  • Pregnant
  • Prior germline genetic testing with a 40+ multi-gene panel AND/OR prior somatic tissue (250+ gene) testing utilizing the tissue from the bronchoscopy or surgical resection

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients receive genomic counseling and genomic testing education, undergo blood or saliva collection, provide previously collected tissue sample and have medical records reviewed on study. Patients and healthcare providers receive results of any genetic variants found on testing.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Percent of samples adequate for sequencing [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Janani S. Reisenauer, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-08.