Evaluating genetic testing for suspected lung cancer
Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)
This study is testing if robotic biopsies can help find genetic markers in patients suspected of having lung cancer to improve future treatments and share important results with them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06482073 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing the effectiveness of robotic biopsies in identifying hereditary or cancer-specific genetic variants in patients suspected of having lung cancer. The primary objectives include ensuring that at least 80% of samples are adequate for whole exome sequencing and developing a databank of genetic data for future research. Participants will receive genomic counseling, undergo blood or saliva collection, and provide previously collected tissue samples while their medical records are reviewed. Results of any genetic variants found will be shared with patients and healthcare providers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for a bronchoscopy and have a moderate to high risk of lung cancer.
Not a fit: Patients who are pregnant, institutionalized, or have had recent extensive genetic testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with suspected lung cancer.
How similar studies have performed: Other studies have shown promise in using genetic testing for cancer diagnosis, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Janani S. Reisenauer, M.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.