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Recruiting

NCT Number: NCT06482073

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Janani S. Reisenauer, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Percent of samples adequate for sequencing

    Time frame: 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 outcomes

  1. Data bank of genomic data

    Time frame: Up to 2 years

    A data bank of genomic data will be developed for future analyses.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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