CClinicalTrials.gg
RecruitingNCT00471978Updated Oct 7, 2026

DNA Analysis of Blood and Tissue From Patients With Lung Cancer

An observational study in Lung Cancer, sponsored by Massachusetts General Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Massachusetts General Hospital · Observational

From the registry’s dates

  • Started Sep 2005; still recruiting 21 years 1 month later.
Updated Oct 7, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
15,000
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed 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 early phases of this study. Total enrollment to reach 15,000.

02

Conditions studied

  • Lung Cancer

Keywords

  • non-small cell lung cancer
  • small cell lung cancer
  • pulmonary carcinoid tumor
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with lung cancer

Eligibility criteria

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.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
15,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Metabolic polymorphisms

    to compare differences among lung cancer patients

    Time frame: 10 years

07

Study locations

2 of 2 sites recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    • Clinical Trials Office - Massachusetts General Hospital · Contact · 877-726-5130
    Recruiting
  • Harvard School of Public Health
    Boston, Massachusetts 02115, United States
    • David C. Christiani, MD · Contact · 617-726-9274
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 2026→Sep 2028
Oct 7, 2026
Study completion
Sep 2026→Sep 2028
Oct 7, 2026
Also revised
eligibility
Show all 1 update
  1. Oct 7, 2026
    Primary completion Sep 2026→Sep 2028
    Study completion Sep 2026→Sep 2028
    Eligibility Criteria revised
    + 4 other changes: index terms, identifiers, verification date and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00471978
Lead sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
David Christopher Christiani (Elkan Blout Professor of Enviromental Genetics, Professor of Medicine, Massachusetts General Hospital) — Principal investigator
First posted
May 10, 2007
Start date
Sep 2005
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 7, 2026

Study contacts

David C. Christiani, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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