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DNA Analysis of Blood and Tissue From Patients With Lung Cancer

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Sep 2026 → Sep 2028
See other at-risk trials from Massachusetts General Hospital

Amendment history

  1. Notable

    Primary and study completion pushed from Sep 2026 to Sep 2028

    Enrollment changed: None → 15000; Eligibility criteria expanded, about 5 words; Study description expanded, about 6 words

    Show what changed: 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 exclude [...]
    Show what changed: Study 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 gene [...] ung-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 di [...] loratory gene-gender-diet and gene-gene-diet interactions). * Assess the role of polymorphisms on the risk of developing s [...] c histologic subtypes of lung cancer in case-only analyses. * Determine whether continued exposures to mai [...]

  2. Notable

    Primary completion date: Jun 2023 to Sep 2026

    Enrollment target: 6800 to not stated; Completion date: Sep 2023 to Sep 2026; Study description expanded, about 8 words

    Show what changed: Study description
    [...] al of 3,400 patients and 3,400 controls will be accrued for early phases of this study. Total enrollment to reach 15,000.

    Study Identification, Study Status, Study Description, Study Design, Eligibilityv20

  3. Notable

    Primary completion date: Jun 2022 to Jun 2023

    Completion date: Sep 2022 to Sep 2023; Eligibility criteria shortened, about 17 words; Study description expanded, about 6 words

    Show what changed: Eligibility criteria
    DISEASE CHARACTERISTICS: Patient: Newly diagnosed primary lung cancer Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center Control: Nonblood-related friend or spouse of the patient No specific matching characteristics Friend or spouse of other hospital patients PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified EXCLUSIONS: Healthy controls with other primary cancers (melanoma, colon, etc.) are excluded Vulnerable populations are excluded. Patients with metastasis from another site to lung or mesothelioma are excluded.
    Show what changed: Study description
    [...] rognosis in patients treated for lung cancer. OUTLINE: This isbegan as a case-control study, but is currently case only. Blood samples are collected from patients and controls. Sa [...]

    Study Status, Study Description, Eligibilityv19

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v18

  5. Notable

    Primary completion date: Jun 2017 to Jun 2022

    Completion date: Sep 2017 to Sep 2022

    Study Statusv17

Show 15 earlier versions

  1. Notable

    Primary completion date: Jun 2011 to Jun 2017

    Completion date: Sep 2017; Eligibility criteria expanded, about 16 words

    Show what changed: Eligibility criteria
    [...] STICS: Not specified PRIOR CONCURRENT THERAPY: Not specified EXCLUSIONS: Healthy controls with other primary cancers (melanoma, colon, etc.) are excluded Vulnerable populations are excluded

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility, IPDSharingv16

  2. Minor

    Interventions: laboratory biomarker analysis (Other), polymerase chain reaction (Genetic), polymorphism analysis (Genetic) to diagnostic laboratory biomarker analysis (Other), polymerase chain reaction (Genetic), polymorphism analysis (Genetic)

    Study Status, Arms and Interventionsv15

  3. Notable

    Primary completion date: Apr 2009 to Jun 2011

    Study Statusv14

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v13

  5. Minor

    Interventions: laboratory biomarker analysis (Procedure), polymerase chain reaction (Procedure), polymorphism analysis (Procedure) to laboratory biomarker analysis (Other), polymerase chain reaction (Genetic), polymorphism analysis (Genetic)

    Study Status, Arms and Interventionsv12

  6. Minor

    2 amendments

    2 re-verifications since 2008-07-23, no change to tracked fields

    v10-v11

  7. Minor

    Interventions: diagnostic procedure (Procedure), laboratory biomarker analysis (Procedure), molecular genetic technique (Procedure), polymerase chain… to laboratory biomarker analysis (Procedure), polymerase chain reaction (Procedure), polymorphism analysis (Procedure)

    Study Status, Arms and Interventionsv9

  8. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  9. Minor

    Primary completion date: Apr 2009

    Study Statusv7

  10. Minor

    Start date: Sep 2005

    Study Statusv6

  11. Minor

    Interventions: diagnostic test (Procedure), genetic analysis (Procedure), laboratory biomarker analysis (Procedure), polymerase chain reaction… to diagnostic procedure (Procedure), laboratory biomarker analysis (Procedure), molecular genetic technique (Procedure), polymerase chain…

    Study Status, Arms and Interventionsv5

  12. Minor

    Interventions: biological markers (Procedure), diagnostic test (Procedure), genetic analysis (Procedure), polymerase chain reaction (Procedure)… to diagnostic test (Procedure), genetic analysis (Procedure), laboratory biomarker analysis (Procedure), polymerase chain reaction…

    Study Status, Arms and Interventionsv4

  13. Minor

    Study Status, Study Design, Outcome Measures

    v3

  14. Minor

    Study sites revised (2)

    Show what changed: Study sites
    Massachusetts General Hospital Cancer Center

    Study Status, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00471978
Lead Sponsor Massachusetts General Hospital
Collaborators: National Cancer Institute (NCI)
Conditions Lung Cancer
Enrollment 15,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov