Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung
Conditions
Brief summary
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.
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
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of samples adequate for sequencing | 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
| Measure | Time frame | Description |
|---|---|---|
| Data bank of genomic data | Up to 2 years | A data bank of genomic data will be developed for future analyses. |
Countries
United States
Contacts
CONTACTThoracic Research
PRINCIPAL_INVESTIGATORJanani S. Reisenauer, M.D.
Mayo Clinic in Rochester
Outcome results
None listed