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

Recruiting

• Conditions: Metastatic Malignant Neoplasm in the Lung; Lung Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06482073
• Lead Sponsor: Mayo Clinic

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.

Detailed 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.

Study Timeline

• Study Start: 2024-06-24
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• * Subject age 18 years and older

  • Subject is 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
  • Enrolled in study IRB#16-009655
  • 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Percent of samples adequate for sequencing	Up to 2 years	Assessed based on the number of tissue samples determined to be adequate for WES (Whole Exome Sequencing)/WT (wild-type) sequencing.

Secondary Outcome Measures

Name	Time	Method
Data bank of genomic data	Up to 2 years	A data bank of genomic data will be developed for future analyses.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States