Biospecimen Analysis for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDonald J Johann, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Donald J Johann, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for current or former smokers aged 18-74 with a significant smoking history, who are candidates for lung cancer treatment. It includes those planning surgery or radiation therapy and excludes individuals with certain medical conditions, recent weight loss, or other cancers.

Inclusion Criteria

My lung cancer is scheduled for surgical removal.

I am 18 years old or older.

I have a chronic inflammatory condition like Lupus or Rheumatoid arthritis.

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Exclusion Criteria

I have recently coughed up blood.

I do not have diabetes, heart disease, autoimmune disorders, or hepatitis.

I have had part of my lung removed, but not just by needle biopsy.

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Treatment Details

Interventions

Blood/Urine Sample Collection (Precision Medicine)
Fresh tissue biopsy (Precision Medicine)

Trial OverviewThe study aims to advance precision medicine by collecting blood/urine samples and tissue biopsies from lung cancer patients. These biospecimens will be used to identify genetic mutations and improve liquid biopsy techniques in conjunction with mouse model research.

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Solid tumor cancer w/ radiation therapyExperimental Treatment1 Intervention

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.

Group II: Lung/ Head and Neck Cancer GroupExperimental Treatment2 Interventions

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.

Group III: Lung cancer with planned resectionExperimental Treatment2 Interventions

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.

Group IV: Healthy people who exerciseExperimental Treatment1 Intervention

Blood/Urine Sample Collection Blood and urine collection one time prior to exercise and one time after exercise.

Group V: Chronic inflammatory diseaseExperimental Treatment1 Intervention

Blood/Urine Sample Collection A one time blood and urine sample collection will be completed.

Group VI: At risk for lung cancerExperimental Treatment1 Intervention

Blood/Urine Sample Collection A one time blood and urine sample collection will be completed.