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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the management and early detection of lung cancer by studying blood and urine samples. Researchers will analyze these samples, along with biopsy tissue, to identify genetic mutations and refine a method known as liquid biopsy. The study seeks participants with lung cancer scheduled for surgery, individuals at risk for lung cancer, those with other solid tumors undergoing radiation therapy, and individuals with chronic inflammatory diseases like rheumatoid arthritis. Participants will provide blood and urine samples, and some will also undergo a tissue biopsy. This research could lead to more personalized treatments for lung cancer. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could revolutionize early detection and treatment of lung cancer.

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 prior data suggests that this biospecimen analysis is safe for participants?

Research has shown that collecting blood and urine samples is safe. These tests detect signs of cancer, such as DNA fragments or proteins, in the blood or urine. Studies have not identified any serious side effects from collecting these samples. The process is simple and well-tolerated.

Tissue biopsies are also considered safe. During a biopsy, a small tissue sample is taken to check for cancer. This common test helps doctors determine the presence and type of cancer. Although biopsies can cause some discomfort, serious complications are rare.

Overall, both blood/urine sample collection and tissue biopsy have been used safely in many studies. They are vital tools in cancer research and diagnosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding lung cancer through the analysis of biospecimens like blood, urine, and tissue samples. Unlike traditional treatments that directly target tumors, this study aims to uncover biomarkers and patterns that could lead to earlier detection and more personalized treatment plans. By gathering samples from diverse groups, including those with lung cancer, healthy individuals, and people with other conditions, researchers hope to identify unique indicators of lung cancer progression and response to treatment, potentially revolutionizing how the disease is diagnosed and managed.

What evidence suggests that this trial's methods could be effective for lung cancer management?

This trial collects and analyzes blood, urine, and tissue samples to better understand lung cancer. Participants in different trial arms will provide samples under various conditions. Studies have shown that examining samples like blood and urine can enhance understanding of lung cancer by detecting tiny pieces of genetic material called cell-free DNA mutations in the blood. Identifying these mutations can help doctors detect cancer earlier and customize treatments for each patient. Research suggests that these methods can make cancer care more precise by complementing imaging techniques. This approach also helps track how well patients respond to treatments over time. Overall, this type of analysis shows promise for improving lung cancer screening and treatment plans.

Who Is on the Research Team?

Donald J Johann, MD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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 cancer cannot be removed by surgery and has spread.

My lung cancer is scheduled for surgical removal.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5709129/

Blood-based tumor biomarkers in lung cancer for detection ... In this paper, we review various blood-based biomarkers including circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), tumor derived exosomes, tumor ...

2. cancer.org cancer.org/cancer/screening/multi-cancer-early-detection-tests.html

Multi-cancer Detection (MCD) Tests MCD tests check blood or other body fluid (such as urine or saliva) samples for signs of cancer, such as pieces of DNA, RNA, or proteins from ...

3. aacr.org aacr.org/blog/2024/10/07/urine-tests-can-detecting-cancer-become-easy-pee-sy/

Urine Tests: Can Detecting Cancer Become Easy Pee-sy? Researchers are looking into what cancers could be detected earlier in urine tests, including lung, ovarian, pancreatic, colorectal, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2095927325006565

Review Liquid biopsy-based multi-cancer early detection This review comprehensively examines the advancements in MCED technologies and offers insights into the selection of cancer types for inclusion in MCED panels.

5. nature.com nature.com/articles/s41598-024-79383-2

Non-invasive multiple cancer screening using trained ... The results of the study showed that the SpotitEarly screening test detects malignant lung, breast, colorectal, and prostate tumors in exhaled ...