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NCT06482073 | RECRUITING | Lung Carcinoma

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

Condition or disease

Lung Carcinoma

Metastatic Malignant Neoplasm in the Lung

Intervention/treatment

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
Estimated Enrollment : 100 participants
Official Title : Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)
Actual Study Start Date : 2024-06-24
Estimated Primary Completion Date : 2027-07-01
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)

Location Details

NCT06482073

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905