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Biospecimen Analysis for Lung Cancer

N/A

Waitlist Available

Led By Donald J Johann, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lung cancer with planned resection

Age 18 years and older

Must not have

Recent hemoptysis

People will be excluded if they have self-reported any of the following conditions: diabetes, heart disease, autoimmune disorders or hepatitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating how well different types of biospecimens can be used to screen for and manage lung cancer, with the goal of developing precision medicine. A co-clinical trial approach will be used, meaning data from the treatment of genetic mouse models of lung cancer will be compared with clinical samples and data from lung cancer patients.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since the interventions involve sample collection and biopsies, potential side effects may include discomfort at the collection site, bleeding, infection risk from the procedures, and possible adverse reactions in people sensitive to such interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is scheduled for surgical removal.

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I am 18 years old or older.

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My cancer cannot be removed by surgery and has spread.

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I have never smoked or I quit smoking in the last six months.

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I have smoked at least 30 pack-years.

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I have cancer and will be treated with radiation.

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I am between 45 and 74 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recently coughed up blood.

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

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

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I have no significant cognitive impairments that would prevent me from fully participating.

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I have Hepatitis C, Rheumatoid Arthritis, or have had an organ transplant.

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I have had lung cancer in the past.

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I have been treated for pneumonia or a lung infection with antibiotics in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of genomic profile

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 14Eligibility criteria met