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NCT02597738Active, not recruiting

A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine

Scientific and Methodological Advancements in Human Specimens to Further the Development of Lung Cancer-based Precision Medicine - A Feasibility Study

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
330 (estimated)
First submitted
28 Oct 2015
Start date
Jan 2016
Primary completion date
Dec 2027
Lead sponsor
University of Arkansas
NCT number
NCT02597738

What you commit to

  • Study type: Interventional
  • Planned participants: 330
  • From Jan 2016 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Cohort A (Lung/Head and Neck Cancer Group) Inclusion criteria:
  • Unresectable metastatic lung cancer or head and neck cancer or other solid tumor malignancy
  • Current or Former Smokers with greater than or equal to 10 pack year smoking history
  • Candidates for standard or experimental treatment as determined by their treating physician
  • Age 18 years and older
  • Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
    • Cohort A (Lung/Head and Neck Cancer Group) Exclusion criteria:
  • Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
  • Existing diagnosis or evidence of Hepatits C, Rheumatoid Arthritis or any previous solid organ transplant.
  • Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
  • Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
  • Other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
    • Cohort B (Chronic Inflammatory disease) Inclusion criteria:
  • Chronic inflammatory disease including but not limited to:
    • Systematic Lupus Erythematosus
    • Rheumatoid arthritis
    • Hepatitis C
    • Ankylosing Sponsylitis
    • Scleroderma
  • No history of smoking or quit smoking within the last six months
  • Age 18 years and older
  • Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
    • Cohort B (Chronic inflammatory disease) Exclusion criteria:
    • 1\. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen. 2. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
    • 3\. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol.
    • 4\. Other current malignancy(s). Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
    • 5\. No current steroid treatment or treatment within the last 3 months.
    • Cohort C (At risk for lung cancer) Inclusion criteria:
  • Age 45-74 years
  • Former or current smokers with a 30 or more pack-years of cigarette smoking history
  • Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
    • Cohort C (At risk for lung cancer) Exclusion criteria:
  • Other current malignancy(s). Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
  • History of lung cancer
  • History of removal of any portion of the lung, excluding needle biopsy
  • Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment
  • Recent hemoptysis
  • Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment.
  • History of abnormal chest CT examination suspicious for cancer in the 18 months prior to eligibility assessment.
    • 9\. Chronic inflammatory disease including but not limited to:
  • Systematic Lupus Erythematosus
  • Rheumatoid arthritis
  • Hepatitis C
  • Ankylosing Sponsylitis
  • Scleroderma
    • Cohort D (healthy people who exercise) Inclusion criteria:
  • Age 18 years and older
  • Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  • Must complete and self-report vigorous exercise for 30 minutes
    • Cohort D (healthy people who exercise) Exclusion criteria:
    • 1\. People will be excluded if they have self reported any of the following conditions: diabetes, heart disease, autoimmune disorders or hepatitis.
    • Cohort E (lung cancer with planned resection) Inclusion criteria:
  • Age 18 years and older
  • Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  • Lung cancer with planned resection.
    • Cohort E (lung cancer with planned resection) Exclusion criteria:
  • Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the protocol
  • Existing diagnosis or evidence of Hepatits C, Rheumatoid Arthritis or any previous solid organ transplant.
    • Cohort F (Any solid tumor cancer with radiation therapy) Inclusion criteria:
  • Age 18 years and older
  • Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  • Any solid tumor cancer and will receive radiation therapy.
    • Cohort F (Any solid tumor cancer with radiation therapy) Exclusion criteria:
    • 1\. Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the protocol 3. Existing diagnosis or evidence of Hepatits C, Rheumatoid Arthritis or any previous solid organ transplant.

Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Arkansas for Medical Sciences
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.