NCT02597738

A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine

Scientific and Methodological Advancements in Human Specimens to Further the Development of Lung Cancer-based Precision Medicine - A Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to further advancements in biospecimens (blood cellular free component, e.g., plasma, serum, tissue, urine), in order to develop precision medicine, for lung cancer management and lung cancer screening (synergy with imaging). A co-clinical trial approach, with integrative analyses leveraging data from the treatment of genetic mouse models of lung cancer along with clinical samples and data from lung cancer patients, will be used to elucidate genomic background metrics, identify cell free DNA mutations, and further refine the liquid biopsy approach. Blood and urine samples will be analyzed for different genetic components. The tissue biopsy will be implanted into a mouse and after the cancer grows in the mouse the cancer DNA from the mouse will be compared with the human blood.

Detailed description

This is a feasibility study to collect tumor and peripheral blood and urine of patients with lung cancer, or head and neck cancer, or other solid tumor who receive treatment. Blood and urine will also be collected from subjects without cancer to assess non cancer profiles. To conduct this study, a total of 30 study-eligible subjects of all races and ethnicities, aged 18 years or older with a diagnosis of cancer of the lung or head and neck cancer or other solid tumor malignancy (Cohort A), will be enrolled and have their tumor collected once for molecular profiling and xenograft development and blood collected at prespecified time intervals until completion of treatment for liquid biopsy analysis (targeted sequencing, whole exome sequencing, whole genome sequencing). A total of 140 study-eligible subjects of all races and ethnicities ages 18 years or older will be enrolled in the non-lung cancer control subgroups for chronic inflammatory disorder (Cohort B), people at risk to develop lung cancer (Cohort C) and healthy people who complete vigorous exercise (Cohort D). A total of 180 subjects will be enrolled into the resection and radiation therapy cancer cohorts (Cohorts E and F).

Conditions

• Lung Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	Fresh tissue biopsy	Fresh tissue biopsy will be collected.
OTHER	Blood/Urine Sample Collection	A one time blood sample will be collected.

Timeline

• Start date: 2016-01-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2015-11-05
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States