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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of genomic profile
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.
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Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
149,971 Total Patients Enrolled
Donald J Johann, MDPrincipal InvestigatorUniversity of Arkansas
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have lost more than 15 pounds in the last year without trying.My lung cancer is scheduled for surgical removal.I have no significant cognitive impairments that would prevent me from fully participating.I am 18 years old or older.I have a chronic inflammatory condition like Lupus or Rheumatoid arthritis.My cancer cannot be removed by surgery and has spread.I have never smoked or I quit smoking in the last six months.I have been cancer-free for 5 years or my only past cancers were non-invasive.I have smoked at least 30 pack-years.You must be able to do intense exercise for 30 minutes and be able to tell us about it.I have Hepatitis C, Rheumatoid Arthritis, or have had an organ transplant.My doctor has approved me for standard or experimental cancer treatments.I haven't taken steroids in the last 3 months.You have smoked an average of at least one pack of cigarettes per day for 10 years or more.I have had lung cancer in the past.I have cancer and will be treated with radiation.I had a chest CT scan that showed possible cancer within the last 18 months.I am between 45 and 74 years old.I have been treated for pneumonia or a lung infection with antibiotics in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Lung cancer with planned resection
- Group 2: At risk for lung cancer
- Group 3: Healthy people who exercise
- Group 4: Solid tumor cancer w/ radiation therapy
- Group 5: Lung/ Head and Neck Cancer Group
- Group 6: Chronic inflammatory disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total sample size of participants for this experiment?
"Affirmative. The information published on clinicaltrials.gov confirms that this investigation is presently accepting participants; it was initially advertised on January 1st 2016 and the most recent update to its details occurred October 26th 2022. A total of 330 individuals are being sought at a single location for inclusion in the study."
Answered by AI
What are the requirements for participating in this research study?
"This clinical trial seeks 330 individuals between 18 and 99 years old who are currently or formerly smokers with a minimum of 10 pack year smoking history, have been diagnosed with an inoperable metastatic lung cancer, head and neck cancer, or another form of solid tumor malignancy. In addition to meeting these prerequisites, prospective participants must sign a UAMS IRB-approved informed consent prior to being accepted into cohort A (Lung/Head and Neck Cancer Group)."
Answered by AI
Is it permissible for individuals over 45 to partake in this investigation?
"This clinical trial is open to participants who are aged 18 or above, but not exceeding 99 years old."
Answered by AI
Is it possible to enroll in this investigation now?
"Affirmative. Clinicaltrials.gov's records indicate that the search for trial participants is ongoing, as it was initially posted on January 1st 2016 and last updated October 26th 2022. There are 330 positions to fill at a single medical facility involved in this project."
Answered by AI
Who else is applying?
What site did they apply to?
University of Arkansas for Medical Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I have stage 2 copd and having a hard time stopping smoking my sister and father both died of lung cancer in there 60aim concerned.
PatientReceived no prior treatments
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