Biospecimen Analysis for Lung Cancer

Overseen By Sorena Lo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Steroids

Disqualifiers: Hepatitis C, Rheumatoid Arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

330 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on steroid treatment, you may not be eligible for Cohort B. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Blood/Urine Sample Collection, Fresh tissue biopsy for lung cancer?

Research shows that using urine and blood samples to detect specific genetic changes in lung cancer can help identify patients who might benefit from targeted therapies. This non-invasive method is easier and less risky than traditional tissue biopsies, and it has been shown to effectively monitor cancer mutations and treatment responses. ^{1 2 3 4 5}

Is it safe to participate in a clinical trial involving biospecimen analysis for lung cancer?

The safety of lung biopsies, which are part of biospecimen analysis, has been studied, but mostly in small groups. There have been reports of adverse events, so it's important to discuss potential risks with your healthcare provider. ^{2 6 7 8 9}

How does this treatment for lung cancer differ from other treatments?

This treatment is unique because it uses liquid biopsies, which analyze blood and other body fluids to provide a real-time understanding of cancer evolution, unlike traditional tissue biopsies that can't capture the dynamic nature of cancer. ^{2 10 11 12 13}

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 have a chronic inflammatory condition like Lupus or Rheumatoid arthritis.

My cancer cannot be removed by surgery and has spread.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Blood and urine samples are collected from participants, with tissue biopsies for some groups

Throughout the study

Multiple visits for sample collection

Treatment Monitoring

Participants with cancer receive treatment and are monitored through blood and urine sample collections

1 year

Every 2-4 weeks

Follow-up

Participants are monitored for genomic changes and response to treatment

Up to 5 years

Annual visits

Treatment Details

Interventions

• Blood/Urine Sample Collection
• Fresh tissue biopsy

Trial Overview 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.

Participant Groups

Group I: Solid tumor cancer w/ radiation therapy Experimental Treatment 1 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 Group Experimental Treatment 2 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 resection Experimental Treatment 2 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 exercise Experimental Treatment 1 Intervention

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

Group V: Chronic inflammatory disease Experimental Treatment 1 Intervention

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

Group VI: At risk for lung cancer Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

A study analyzing data from 540,747 lung cancer patients revealed that the incidence of adverse events during lung biopsies increased significantly from 24% in 2001 to 38% in 2010, indicating a growing concern for patient safety.

Patients who experienced adverse events had longer hospital stays and a significantly higher risk of in-hospital mortality, with an adjusted odds ratio of 5.9, highlighting the need for improved safety measures in lung biopsy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. von Itzstein, MS., Gupta, A., Mara, KC., et al.[2020]

The PLCO cancer screening trial has created a valuable biorepository by collecting blood and tumor tissue samples from participants, which aids in understanding cancer causes and developing treatment strategies.

This biorepository is unique because it includes serial samples collected before cancer diagnosis, along with extensive epidemiological data, making it a rich resource for cancer research and biomarker identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PLCO Biorepository: Creating, Maintaining, and Administering a Unique Biospecimen Resource. Carrick, DM., Black, A., Gohagan, JK., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Utility of Cell-free and Circulating Tumor DNA in Kidney and Bladder Cancer: A Critical Review of Current Literature. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Bladder cancer biorepositories in the "-omics" era: integrating quality tissue specimens with comprehensive clinical annotation. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Genomic complexity of urothelial bladder cancer revealed in urinary cfDNA. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

EGFR Genotyping of Matched Urine, Plasma, and Tumor Tissue in Patients With Non-Small-Cell Lung Cancer Treated With Rociletinib, an EGFR Tyrosine Kinase Inhibitor. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Urine test for EGFR analysis in patients with non-small cell lung cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. [2020]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The PLCO Biorepository: Creating, Maintaining, and Administering a Unique Biospecimen Resource. [2020]

8. China pubmed.ncbi.nlm.nih.gov

From tissue to molecular phenotyping: pre-analytical requirements heidelberg experience. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Cohort profile: King's Health Partners bladder cancer biobank. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Liquid biopsies and cancer omics. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Biopsies: next-generation biospecimens for tailoring therapy. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The Texas Immuno-Oncology Biorepository, a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Innovative methodology for the identification of soluble biomarkers in fresh tissues. [2019]