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

Mayo Clinic

Status: Enrolling

Conditions: Lung Carcinoma; Metastatic Malignant Neoplasm in the Lung

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06482073

NCI-2024-04855 (Registry Identifier)

24-000609 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Assessing whether the percentage of samples adequate for WES (Whole Exome Sequencing)/WT (Wild-Type) sequencing is at least 80%.

II. Development of a data bank of WES/WT and germline sequencing data for future analyses.

OUTLINE: This is an observational study.

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

100 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Non-Interventional Study