NCT02597738

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
18mo left

Started Jan 2016

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2016Dec 2027

First Submitted

Initial submission to the registry

October 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

10.9 years

First QC Date

October 28, 2015

Last Update Submit

June 16, 2025

Conditions

Lung CancerHead and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Measurement of genomic profile

    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.

    15 months

Study Arms (6)

Lung/ Head and Neck Cancer Group

EXPERIMENTAL

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.

Other: Fresh tissue biopsyOther: Blood/Urine Sample Collection

Chronic inflammatory disease

EXPERIMENTAL

Blood/Urine Sample Collection A one time blood and urine sample collection will be completed.

Other: Blood/Urine Sample Collection

At risk for lung cancer

EXPERIMENTAL

Blood/Urine Sample Collection A one time blood and urine sample collection will be completed.

Other: Blood/Urine Sample Collection

Healthy people who exercise

EXPERIMENTAL

Blood/Urine Sample Collection Blood and urine collection one time prior to exercise and one time after exercise.

Other: Blood/Urine Sample Collection

Lung cancer with planned resection

EXPERIMENTAL

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 biopsyOther: Blood/Urine Sample Collection

Solid tumor cancer w/ radiation therapy

EXPERIMENTAL

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.

Other: Blood/Urine Sample Collection

Interventions

Fresh tissue biopsyOTHER

Fresh tissue biopsy will be collected.

Lung cancer with planned resectionLung/ Head and Neck Cancer Group
Blood/Urine Sample CollectionOTHER

A one time blood sample will be collected.

At risk for lung cancerChronic inflammatory diseaseHealthy people who exerciseLung cancer with planned resectionLung/ Head and Neck Cancer GroupSolid tumor cancer w/ radiation therapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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)
  • \. 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.
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsHead and Neck Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Donald J Johann, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 5, 2015

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)