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Lung Cancer Biomarkers and Screening

Study acronym: NYULCBC
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Enrollment target: 10850 to 3606

    Study Status, Study Designv44

  2. Minor

    Enrollment target: 9350 to 10850

    Study Status, Study Designv43

  3. Minor

    Enrollment target: 6860 to 9350

    Study Status, Study Designv42

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v41

  5. Minor

    Site contact updated

    Study Status, Contacts/Locationsv40

Show 38 earlier versions

  1. Minor

    2 amendments

    2 re-verifications since 2021-04-19, no change to tracked fields

    v38-v39

  2. Notable

    Primary and study completion dates: May 2020 to May 2030

    Study Statusv37

  3. Notable

    Primary and study completion dates: May 2019 to May 2020

    Study Statusv36

  4. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v35

  5. Notable

    Primary and study completion dates: Sep 2018 to May 2019

    Study Statusv34

  6. Notable

    Primary completion date: Sep 2017 to Sep 2018

    Study Status, Oversightv33

  7. Notable

    Primary completion date: Sep 2016 to Sep 2017

    Completion date: Sep 2017 to Sep 2018

    Study Statusv32

  8. Minor

    Completion date: Sep 2017

    Study Statusv31

  9. Notable

    Primary completion date: Jul 2015 to Sep 2016

    Study Statusv30

  10. Minor

    3 amendments

    3 re-verifications since 2013-05-20, no change to tracked fields

    v27-v29

  11. Notable

    Phase: Not applicable to Not specified

    Enrollment target: 1450 to 6860; Primary completion date: Feb 2010 to Jul 2015; Interventions: biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Other), screening questionnaire administration (Other) to not stated; and 6 more

    Show all 10 changes in this update
    • Notable Phase: Not applicable to Not specified
    • Notable Enrollment target: 1450 to 6860
    • Notable Primary completion date: Feb 2010 to Jul 2015
    • Minor Interventions: biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Other), screening questionnaire administration (Other) to not stated
    • Minor Secondary endpoints: details revised at 1 of 1 entry
    • Minor Study description shortened, about 1 word
      Show what changed
      [...] lected from surgery or biopsy. PROJECTED ACCRUAL: A total of 1,450 participants will be accrued for this study.
    • Minor Collaborators shortened, about 4 words
      Show what changed
      National Cancer Institute (NCI)
    • Minor Publications: 1 to 3
      Show what changed
      Greenberg AK, Lu F, Goldberg JD, Eylers E, Tsay JC, Yie TA, Naidich D, McGuinness G, Pass H, Tchou-Wong KM, Addrizzo-Harris D, Chachoua A, Crawford B, Rom WN. CT scan screening for lung cancer: risk factors for nodules and malignancy in a high-risk urban cohort. PLoS One. 2012;7(7):e39403. doi: 10.1 [...]
    • Minor Study title shortened, about 2 words
      Show what changed
      Biomarkers in Screening Participants For Lung Cancer Biomarkers and Screening
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Referencesv26

  12. Minor

    Study Status

    Re-verified, no change to tracked fields

    v25

  13. Minor

    Interventions: biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Procedure), screening questionnaire administration (Procedure) to biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Other), screening questionnaire administration (Other)

    Study Status, Arms and Interventionsv24

  14. Minor

    2 amendments

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

    v22-v23

  15. Notable

    Phase: Not specified to Not applicable

    Study Status, Study Designv21

  16. Minor

    Primary completion date: Feb 2010

    Start date: Oct 2005 to May 2000

    Study Statusv20

  17. Minor

    Start date: Oct 2005

    Study Statusv19

  18. Minor

    Interventions: biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Procedure), screening and diagnostic assessment (Procedure)… to biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Procedure), screening questionnaire administration (Procedure)

    Study Status, Arms and Interventionsv18

  19. Minor

    Publications: details revised at 1 of 1 entry

    Study Status, Referencesv17

  20. Minor

    Interventions: Intervention/procedure (Procedure), behavioral, psychological or informational intervention (Procedure), biomarker analysis (Procedure)… to biopsy (Procedure), bronchoscopy (Procedure), laboratory biomarker analysis (Procedure), screening and diagnostic assessment (Procedure)…

    Study Status, Arms and Interventionsv16

  21. Minor

    Interventions: Intervention/procedure (Procedure), behavioral, psychological or informational intervention (Procedure), biological markers (Procedure)… to Intervention/procedure (Procedure), behavioral, psychological or informational intervention (Procedure), biomarker analysis (Procedure)…

    Study Status, Arms and Interventionsv15

  22. Minor

    Interventions: biological markers (Procedure), biopsies (Procedure), bronchoscopy (Procedure), screening and diagnostic assessment (Procedure), screening… to Intervention/procedure (Procedure), behavioral, psychological or informational intervention (Procedure), biological markers (Procedure)…

    Study Status, Arms and Interventionsv14

  23. Minor

    Study description shortened, about 19 words

    Show what changed: Study description
    [...] ic cellular changes and lesions in these patients. OUTLINE: This is a multicenter study. Participants are stratified according to lung cancer risk status (diagnosed or nondiagnosed lung cancer vs with or without increased risk vs diagnosed nonmalignant nodules) and participating site. Group 1 (screening cohort): Participants complete a questi [...] ests and scans as in group 1. Some participants may undergo fluorescence or ultrathinfiberoptic bronchoscopy based upon CT scan results with transbronchial [...]

    Study Status, Study Description, Conditions, Outcome Measures, Eligibilityv13

  24. Minor

    Study Status

    Re-verified, no change to tracked fields

    v12

  25. Minor

    Study Status, Eligibility

    v11

  26. Minor

    3 amendments

    3 re-verifications since 2007-01-05, no change to tracked fields

    v8-v10

  27. Minor

    Enrollment target: 1450

    Eligibility criteria expanded, about 19 words; Study description expanded, about 9 words

    Show what changed: Eligibility criteria
    [...] pack years* With or without workplace exposure to asbestos NOTE: * Participants with < 20 pack years of smoking are eligible if 50 years of age or older Rule-Out Lung cancer group Referred for evaluation of suspic [...]
    Show what changed: Study description
    [...] vs diagnosed nonmalignant nodules) and participating site. Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary [...] tidetector chest CT scan, sputum induction, and phlebotomy. Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the [...]

    Study Identification, Study Status, Study Description, Conditions, Study Design, Eligibilityv7

  28. Minor

    4 amendments

    4 re-verifications since 2006-05-23, no change to tracked fields

    v3-v6

  29. Minor

    Interventions: biological markers (Procedure), bronchoscopy (Procedure), screening and diagnostic assessment (Procedure), screening intervention… to biological markers (Procedure), biopsies (Procedure), bronchoscopy (Procedure), screening and diagnostic assessment (Procedure), screening…

    Eligibility criteria shortened, about 1 word; Study description expanded, about 8 words; Study title shortened, about 4 words

    Show what changed: Eligibility criteria
    [...] without workplace exposure to asbestos Rule-Out Lung cancer patient group Referred for evaluation of suspicious nodules with 1 o [...] nmalignant nodules (control group) PATIENT CHARACTERISTICS: NoNot pregnancypregnant No prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Not specified
    Show what changed: Study description
    [...] tidetector chest CT scan, sputum induction, and phlebotomy. Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may then undergo lung resections or biopsies and have tissue samples collected. Others may undergo fluorescence or ultrathin bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. ParticipantsSome completeparticipants themay sameundergo questionnairelung and follow the same treatment as in group 1resection. Tissue samples are collected from surgery or biopsy. PROJECTED ACCRUAL: A total of 1 [...]
    Show what changed: Study title
    Biomarkers in Screening Participants Who Are at High- or Low-Risk For Smoking-RelatedLung Cancer

    Study Identification, Study Status, Study Description, Arms and Interventions, Eligibilityv2

  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.
NYU Langone Health
397 trials monitored
See 18 trials at risk
Lung Cancer
4,057 trials monitored
See 218 trials at risk
RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer. PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.
Trial Details
NCT Number NCT00301119
Lead Sponsor NYU Langone Health
Conditions Lung Cancer
Enrollment 3,606 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov