Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)

NCT06482073 | Recruiting

• 2 other identifiers: 24-000609NCI-2024-04855
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of robotic biopsies 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

Outcome Measures

Primary Outcomes (1)

• Percent of samples adequate for sequencing

  Assessed based on the number of tissue samples determined to be adequate for WES (Whole Exome Sequencing)/WT (wild-type) sequencing.

  Up to 2 years

Secondary Outcomes (1)

• Data bank of genomic data

  Up to 2 years

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a bronchoscopy recruited through Mayo Clinic

You may qualify if:

• Subject age 18 years and older
• Subject is scheduled/was scheduled for a bronchoscopy 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

You may not qualify if:

• 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 within the last 1 year of enrollment
• Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Janani S. Reisenauer, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)