A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine
- Conditions
- Lung CancerHead and Neck Cancer
- Interventions
- Other: Blood/Urine Sample CollectionOther: Fresh tissue biopsy
- Registration Number
- NCT02597738
- Lead Sponsor
- University of Arkansas
- Brief 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 330
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chronic inflammatory disease Blood/Urine Sample Collection Blood/Urine Sample Collection A one time blood and urine sample collection will be completed. Lung/ Head and Neck Cancer Group Fresh tissue biopsy Blood/Urine Sample Collection Fresh tissue biopsy A one time fresh tissue biopsy of the patient's lung cancer (outside of their normal standard of care biopsy) will be collected for the research. Patients will also complete research blood and urine sample collections every two to four weeks for one year, then up to 120 days for years two through five. Lung/ Head and Neck Cancer Group Blood/Urine Sample Collection Blood/Urine Sample Collection Fresh tissue biopsy A one time fresh tissue biopsy of the patient's lung cancer (outside of their normal standard of care biopsy) will be collected for the research. Patients will also complete research blood and urine sample collections every two to four weeks for one year, then up to 120 days for years two through five. At risk for lung cancer Blood/Urine Sample Collection Blood/Urine Sample Collection A one time blood and urine sample collection will be completed. Lung cancer with planned resection Fresh tissue biopsy Blood/Urine Sample Collection Blood and/or urine sample collection one time before surgery and one time after surgery. Blood and/or urine sample collection at subsequent visits. Fresh tissue biopsy Tissue sample collection from surgery is there is any tissue considered to be pathological waste that would normally be discarded. Healthy people who exercise Blood/Urine Sample Collection Blood/Urine Sample Collection Blood and urine collection one time prior to exercise and one time after exercise. Lung cancer with planned resection Blood/Urine Sample Collection Blood/Urine Sample Collection Blood and/or urine sample collection one time before surgery and one time after surgery. Blood and/or urine sample collection at subsequent visits. Fresh tissue biopsy Tissue sample collection from surgery is there is any tissue considered to be pathological waste that would normally be discarded. Solid tumor cancer w/ radiation therapy Blood/Urine Sample Collection Blood/Urine Sample Collection Blood and/or urine sample collection prior to radiation treatment. Blood and/or urine collection after completion of radiation therapy. Blood and/or urine collection at subsequent visits for next 5 years.
- Primary Outcome Measures
Name Time Method Measurement of genomic profile 15 months Genomic changes causing lung cancer evolve over the course of illness. The genetic changes may serve as a biomarker for diagnosis and response to treatment. These changes will be measured in human specimens and co-cultured in mice.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States