Detection of Genetic Markers of Lung Cancer

NCT00280202 | Recruiting DMC

• 2 other identifiers: STUDY19060269UPCI #99-053
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• The odds ratio for the risk of lung cancer associated with molecular markers

  No specific time frame

Secondary Outcomes (10)

• To obtain/maintain in cell culture "normal" bronchial epithelial cells(NBECs), tumors, and organoids from subjects undergoing resection for treatment of lung carcinoma and mesothelioma.

  No specific time frame

• To harvest NBEC and lung tumors for evaluation of genetic abnormalities; this will be obtained at the time of bronchoscopy and lung resection.

  No specific time frame

• To perform molecular analysis including PCR amplification, flow cytometry, immunohistochemistry, and gene analysis from NBECs, tumors, adjacent & normal lung, and blood.

  No specific time frame

• To look for mutations and alterations of expression of Fas, Fas ligand, and FADD, three molecules which mediate programmed cell death and have recently been shown to be expressed on multiple tumor cells including lung cancer.

  No specific time frame

• To analyze cytokines present in lavage fluid, tumors, and lung tissues.

  No specific time frame

Interventions

Biopsy of the major carinal area PROCEDURE

Biopsy performed intraoperatively

Biopsy of abnormal & suspicious areas of the bronchial tree PROCEDURE

Biopsy performed intraoperatively

Evaluation of the tumor for DNA mutations PROCEDURE

Tumor tissue is banked for future analysis.

Bronchoalveolar Lavage (BAL) for cytokine analysis PROCEDURE

BAL performed intraoperatively

Correlation of flow cytometric & RT PCR for TNM stage PROCEDURE

Tissues banked for future correlative studies

Analysis of lymph nodes PROCEDURE

Tissues banked for future analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be selected from investigator's clinic.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue, and lymph nodes

MeSH Terms

Conditions

Lung Neoplasms; Carcinogenesis; Chromosome Aberrations

Interventions

Bronchoalveolar Lavage; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques

Study Officials

• Arjun Pennathur, MD

  Professor (with tenure) of Cardiothoracic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjun Pennathur, MD

CONTACT

412-647-7555; pennathura@upmc.edu

Julie Ward, BSN

CONTACT

412-647-8583; wardj@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: June 1, 1996
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)