Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00200486 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Molecular and Genomic Profiling of Head and Neck Tumors

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v21

  2. Notable

    Trial status: Suspended to Recruiting

    Primary and study completion dates: Dec 2025 to Dec 2030; Start date: May 2002 to Oct 1, 2002; Site details revised

    Study Status, Contacts/Locationsv20

  3. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: IRB approval has lapsed. Study suspended until it has been recertified by the IRB.

    Site details revised; Collaborators: 2 to 3

    Show what changed: Collaborators
    National Cancer Institute (NCI)

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, Referencesv19

  4. Minor

    Completion date: Dec 1, 2025 to Dec 2025

    Study Identification, Study Statusv18

  5. Minor

    2 amendments

    2 re-verifications since 2022-02-17, no change to tracked fields

    v16-v17

Show 14 earlier versions

  1. Notable

    Enrollment target: 400 to 1000

    Primary completion date: Dec 2020 to Dec 2025; Completion date: Dec 1, 2020 to Dec 1, 2025; Study site revised

    Show what changed: Study sites
    MontefioreStelby Medical CenterAugustine

    Study Status, Study Design, Contacts/Locations, IPDSharingv15

  2. Notable

    Primary completion date: May 2020 to Dec 2020

    Completion date: May 1, 2020 to Dec 1, 2020

    Study Statusv14

  3. Minor

    2 amendments

    2 re-verifications since 2018-07-30, no change to tracked fields

    v12-v13

  4. Minor

    Completion date: May 1, 2020

    Study Statusv11

  5. Notable

    Primary completion date: May 2016 to May 2020

    Site contact updated; Collaborators: 1 to 2

    Show what changed: Collaborators
    National Institute of Dental and Craniofacial Research (NIDCR)

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv10

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v9

  7. Notable

    Primary completion date: May 2013 to May 2016

    Completion date: Mar 2015 to not stated; Study description expanded, about 16 words; Site contact updated; and 1 more

    Show all 5 changes in this update
    • Notable Primary completion date: May 2013 to May 2016
    • Minor Completion date: Mar 2015 to not stated
    • Minor Study description expanded, about 16 words
      Show what changed
      [...] s using HNSCC tissue arrays. Through DNA microarray analysis and other techniques for looking at genetic and molecular characteristics, a more detailed knowledge of the malignant transformation [...] in these patients may be obtained. This study will seek to characterizeperform comprehensive molecular and genetic profilesprofiling onto 200improve patientsbiomarker development in HNSCC and correlate this data with patient's clinical data. Ultimately it is hoped that tumor specific g [...]
    • Minor Site contact updated
    • Minor Study title shortened, about 9 words
      Show what changed
      Molecular Classificationand Genomic Profiling of Head and Neck Tumors Using cDNA Microarray Analysis to Detect Prognosis and Response to Therapy

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Contacts/Locationsv8

  8. Minor

    5 amendments

    5 re-verifications since 2008-05-20, no change to tracked fields

    v3-v7

  9. Notable

    Enrollment target: 200 to 400

    Primary completion date: May 2013; Completion date: Mar 2005 to Mar 2015; Eligibility criteria expanded, about 15 words; and 2 more

    Show all 6 changes in this update
    • Notable Enrollment target: 200 to 400
    • Minor Primary completion date: May 2013
    • Minor Completion date: Mar 2005 to Mar 2015
    • Minor Eligibility criteria expanded, about 15 words
      Show what changed
      Inclusion Criteria: actual or suspected cancermalignant or non-malignant tumors of the head and neck planned biopsy and/or resection, or availability of paraffin embedded or stored frozen tumor tissue for non-genetic analysis Exclusion Criteria: insufficient tissue available for both standard diagnostic evaluation and study specimen -
    • Minor Study description shortened, about 26 words
      Show what changed
      [...] is with treatment response, both surgical and non-surgical. To identify a group of genes which are associated with prognosis, develop a microarray with these genes, and determine if prediction of outcome and treatment response is possible prior to therapy. To identify a series of diagnostic markers in blood, urine and/or sputum for head and neck squamous cell carcinoma and study the mechanism of action of these proteins.
    • Minor Study title shortened, about 2 words
      Show what changed
      Molecular Classification of Head and Neck Squamous Cell CarcinomaTumors Using cDNA Microarray Analysis to Detect Prognosis and Response to Therapy

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Outcome Measures, 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.
The purpose of this study is to study the genetic profile of head and neck tumors and their relationship to treatment response and outcome
Trial Details
NCT Number NCT00200486
Lead Sponsor Montefiore Medical Center
Collaborators: National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI)
Conditions Head and Neck Neoplasms
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov