Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

NCT01139944 | Completed

• 2 other identifiers: ACOSOG-Z4102CDR0000671680
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients with early-stage non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (2)

• disease specific survival

  Up to 10 years

• overall survival

  Up to 10 years

Study Arms (1)

Group 1

Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Genetic: DNA methylation analysis; Genetic: polymerase chain reaction; Other: laboratory biomarker analysis

Interventions

DNA methylation analysis GENETIC

Group 1

polymerase chain reaction GENETIC

Group 1

laboratory biomarker analysis OTHER

Group 1

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

Patients diagnosed with early stage non-small cell lung cancer and previously enrolled on ACOSOG-Z0040 and Z0030.

DISEASE CHARACTERISTICS: * Diagnosis of early-stage non-small cell lung cancer * T1 or T2, N0 disease * Had a lobectomy or greater resection with negative surgical margins (R0 resection) * Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials * Node-negative with recurrent disease within 3 years (cases) * Node-negative patients without recurrent disease (controls) PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

tissue and blood samples

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

DNA Methylation; Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Malcolm V. Brock, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 6, 2016

Record last verified: 2016-07