Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Percent of samples adequate for sequencing [Time frame: Up to 2 years]
Secondary outcome measures (1)
- Data bank of genomic data [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06482073 · 24-000609 · NCI-2024-04855 · 24-000609