DNA Analysis of Blood and Tissue From Patients With Lung Cancer

Lung Cancer Clinical Trial

Official title:

Molecular and Genetic Analysis of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00471978
• Other study ID #: CDR0000450128
• Secondary ID: MGH-1999-P-00493
• Status: Recruiting
• Start date: September 2005
• Est. completion date: September 2023

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood and 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. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Description:

OBJECTIVES:

• Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.

• Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.

• Assess the roles of gender and age in the genetic susceptibility of lung cancer.

• Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).

• Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.

• Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.

OUTLINE: This began as a case-control study, but is currently case only.

Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.

Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.

PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6800
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Patient:

• Newly diagnosed primary lung cancer

• Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

EXCLUSIONS:

Vulnerable populations are excluded. Patients with metastasis from another site to lung or mesothelioma are excluded.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic polymorphisms	to compare differences among lung cancer patients	10 years