Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma; Metastatic Malignant Neoplasm in the Lung
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Thoracic Research; Phone Number: 507-293-0807; Email: RSTTHORACICRES@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Janani S. Reisenauer, M.D.
      • Contact: Thoracic Research; Phone Number: 507-293-0807; Email: RSTTHORACICRES@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a bronchoscopy recruited through Mayo Clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data bank of genomic data	A data bank of genomic data will be developed for future analyses.	Up to 2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Janani S. Reisenauer, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 24-000609 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-04855 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No