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

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ClinicalTrials.gov Identifier: NCT02597738
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The purpose of this study is to further advancements in biospecimens (blood cellular free component, e.g., plasma, serum, tissue), 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Fresh tissue biopsy and blood collection Other: Blood Sample Collection Not Applicable

Detailed Description:
This is a feasibility study to collect tumor and peripheral blood of patients with advanced NSCLC who receive treatment. Blood will also be collected from subjects without lung cancer to assess non cancer profiles. To conduct this study, a total of 30 study-eligible subjects of all races and ethnicities, aged 18 years or older with a diagnosis of Stage IV adenocarcinoma of the lung (Cohort A), will be enrolled and have their tumor collected once for molecular profiling and xenograft development and blood collected at prespecified time intervals until completion of treatment for liquid biopsy analysis (targeted sequencing, whole exome sequencing, whole genome sequencing). A total of 60 study-eligible subjects of all races and ethnicities ages 18 years or older will be enrolled in the non-lung cancer control subgroups chronic inflammatroy disorder (Cohort B), smokers at risk to develop lung cancer (Cohort C).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Scientific and Methodological Advancements in Human Specimens to Further the Development of Lung Cancer-based Precision Medicine - A Feasibility Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cohort A: Lung Cancer Group
Cohort A: Fresh tissue biopsy and blood collection 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 sample collections every two to four weeks for one year.
Other: Fresh tissue biopsy and blood collection
Fresh tissue biopsy and research blood work samples will be collected for one year.

Experimental: Cohort B: Chronic inflammatory disease
Non-Smokers with chronic inflammatory diseases - A one time blood sample collection will be completed.
Other: Blood Sample Collection
A one time blood sample will be collected.

Experimental: Cohort C: Smokers without lung cancer
Smokers without lung cancer - A one time blood sample collection will be completed.
Other: Blood Sample Collection
A one time blood sample will be collected.




Primary Outcome Measures :
  1. Measurement of genomic profile [ Time Frame: 15 months ]
    Genomic changes causing lung cancer evolve over the course of illness. The genetic changes may serve as a biomarker for diagnosis and response to treatment. These changes will be measured in human specimens and co-cultured in mice.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Cohort A (Lung Cancer Group)

  1. Stage IV Non-Small Cell Lung Cancer
  2. Adenocarcinoma histology
  3. Current or Former Smokers with greater than or equal to 10 pack year smoking history - See Appendix A)
  4. Candidates for standard or experimental treatment as determined by their treating physician
  5. Age 18 years and older
  6. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)

Cohort B (Exercise Group)

  1. Age 18 years and older
  2. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)
  3. Ability to exercise for 30-40 minutes
  4. No Smoking history

Cohort C (Chronic Inflammatory disease) Inclusion criteria:

  1. Chronic inflammatory disease including but not limited to:

    • Systematic Lupus Erythematosus
    • Rheumatoid arthritis
    • Hepatitis C
    • Ankylosing Spondylitis
    • Scleroderma
  2. No history of smoking
  3. Age 18 years and older
  4. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)

Cohort D (At risk for lung cancer)

  1. Age 55-74 years
  2. 30 or more pack-years of cigarette smoking history (Appendix A)
  3. Former smokers: quit smoking within the previous 15 years
  4. Must sign an informed consent approved by the UAMS Institutional Review Board (IRB)

Exclusion Criteria:

Cohort A (Lung Cancer Group)

  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 Diabetes Mellitus, Hepatitis C, Rheumatoid Arthritis or any previous solid organ transplant.
  3. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
  4. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
  5. Other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
  6. 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.

Cohort B (Exercise Group)

  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 Diabetes Mellitus, Hepatitis C, Rheumatoid Arthritis or any previous solid organ transplant.
  3. Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
  4. Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
  5. 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.
  6. Known CAD (required surgery or stent placement in the last 6 months)

Cohort C (Chronic inflammatory disease)

  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.

Cohort D (At risk for lung cancer)

  1. 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.
  2. History of lung cancer
  3. History of removal of any portion of the lung, excluding needle biopsy
  4. Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment
  5. Recent hemoptysis
  6. Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment.
  7. Chest CT examination in the 18 months prior to eligibility assessment.
  8. Diagnosis of Diabetes Mellitus
  9. Chronic inflammatory disease including but not limited to:

    • Systematic Lupus Erythematosus
    • Rheumatoid arthritis
    • Hepatitis C
    • Ankylosing Spondylitis
    • Scleroderma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597738


Contacts
Contact: Donald J Johann, MD 501-526-6924 djjohann@uams.edu
Contact: Beth Scanlan 501-686-8274 bscanlan@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Sandy Annis, BA    501-686-8274    amannis@uams.edu   
Principal Investigator: Donald J Johann, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Donald J Johann, MD University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02597738     History of Changes
Other Study ID Numbers: 204803
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases