Head and Neck Cancer, Lung Cancer
Conditions
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).
Interventions
OTHERFresh tissue biopsy
Fresh tissue biopsy will be collected.
OTHERBlood/Urine Sample Collection
A one time blood sample will be collected.
Sponsors
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Cohort A (Lung/Head and Neck Cancer Group) Inclusion criteria: 1. Unresectable metastatic lung cancer or head and neck cancer or other solid tumor malignancy 2. Current or Former Smokers with greater than or equal to 10 pack year smoking history 3. Candidates for standard or experimental treatment as determined by their treating physician 4. Age 18 years and older 5. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB) Cohort A (Lung/Head and Neck Cancer Group)
Exclusion criteria
1. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen 2. Existing diagnosis or evidence of Hepatits C, Rheumatoid Arthritis or any previous solid organ transplant. 3. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol 4. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol 5. Other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen Cohort B (Chronic Inflammatory disease) Inclusion criteria: 1. Chronic inflammatory disease including but not limited to: * Systematic Lupus Erythematosus * Rheumatoid arthritis * Hepatitis C * Ankylosing Sponsylitis * Scleroderma 2. No history of smoking or quit smoking within the last six months 3. Age 18 years and older 4. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB) Cohort B (Chronic inflammatory disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald J Johann, MD
University of Arkansas
Outcome results
None listed