Recruiting

Genetic Markers

Sponsor:

University of Pittsburgh

Code:

NCT00280202

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy of the major carinal area

Biopsy of abnormal & suspicious areas of the bronchial tree

Evaluation of the tumor for DNA mutations

Bronchoalveolar Lavage (BAL) for cytokine analysis

Correlation of flow cytometric & RT PCR for TNM stage

Study Details

Brief summary:

The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.

Conditions

Lung Cancer

Study ID

NCT00280202

Start date

Jun, 1996

Status verified date

Oct, 2025

Completion date

Dec, 2050

Anticipated

Primary completion date

Dec, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologic confirmation of lung cancer, lung metastases from a primary site other than lung, mesothelioma or a radiographic lesion highly suspicious for malignancy
  • Written informed consent.
  • To be scheduled for a biopsy or surgical resection or have already had a biopsy and/or surgical removal of a lung mass

Exclusion Criteria:

None

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Biopsy of the major carinal area

Biopsy performed intraoperatively

Biopsy of abnormal & suspicious areas of the bronchial tree

Biopsy performed intraoperatively

Evaluation of the tumor for DNA mutations

Tumor tissue is banked for future analysis.

Bronchoalveolar Lavage (BAL) for cytokine analysis

BAL performed intraoperatively

Correlation of flow cytometric & RT PCR for TNM stage

Tissues banked for future correlative studies

Analysis of lymph nodes

Tissues banked for future analysis

Primary outcome measure

  • The odds ratio for the risk of lung cancer associated with molecular markers [ Time Frame: No specific time frame ]

Central Contacts and Locations

Central contacts

Arjun Pennathur, MD

412-647-7555pennathura@upmc.edu

Julie Ward, BSN

412-647-8583wardj@upmc.edu

Locations

Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Julie A Ward, BSN

412-647-8583wardj@upmc.edu

Principal Investigator:

Arjun Pennathur, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • Lung cancer
  • Carcinogenesis
  • Genomic changes leading to malignant phenotypes in NSCLC.
  • Simultaneous mutagenesis of epithelial cells.
  • Chromosomal abnormalities/mutations in bronchial tissues.
  • Detect micrometastases in histologically neg. lymph nodes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-10-24.