A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02597738 |
Recruitment Status :
Active, not recruiting
First Posted : November 5, 2015
Last Update Posted : August 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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Lung Cancer Head and Neck Cancer | Other: Fresh tissue biopsy Other: Blood/Urine Sample Collection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 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 2024 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
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Experimental: Lung/ Head and Neck Cancer Group
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.
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Other: Fresh tissue biopsy
Fresh tissue biopsy will be collected. Other: Blood/Urine Sample Collection A one time blood sample will be collected. |
Experimental: Chronic inflammatory disease
Blood/Urine Sample Collection A one time blood and urine sample collection will be completed.
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Other: Blood/Urine Sample Collection
A one time blood sample will be collected. |
Experimental: At risk for lung cancer
Blood/Urine Sample Collection A one time blood and urine sample collection will be completed.
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Other: Blood/Urine Sample Collection
A one time blood sample will be collected. |
Experimental: Healthy people who exercise
Blood/Urine Sample Collection Blood and urine collection one time prior to exercise and one time after exercise.
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Other: Blood/Urine Sample Collection
A one time blood sample will be collected. |
Experimental: Lung cancer with planned resection
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. |
Other: Fresh tissue biopsy
Fresh tissue biopsy will be collected. Other: Blood/Urine Sample Collection A one time blood sample will be collected. |
Experimental: Solid tumor cancer w/ radiation therapy
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.
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Other: Blood/Urine Sample Collection
A one time blood sample will be collected. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
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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.
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
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Donald J Johann, MD | University of Arkansas |
Responsible Party: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT02597738 |
Other Study ID Numbers: |
204803 |
First Posted: | November 5, 2015 Key Record Dates |
Last Update Posted: | August 21, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |