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Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 413 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Trial completed

    Study Statusv413

  2. Minor

    Completion date: Mar 31, 2026

    Study Statusv412

  3. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 156 of 156 sites

    Study Status, Contacts/Locationsv411

  4. Minor

    Start date: Mar 22, 2004 to Mar 25, 2004

    Study Statusv410

  5. Minor

    3 amendments

    3 re-verifications since 2022-08-02, no change to tracked fields

    v407-v409

Show 43 earlier versions

  1. Minor

    Eligibility criteria shortened, about 4 words

    Study description shortened, about 1 word

    Show what changed: Eligibility criteria
    [...] crual Submission of a blood specimen (or in certain cases a buccal cellsaliva specimen) to the ClinicalCoordinating Pharmacokinetics LaboratoryCenter at St.the JudeUniversity Children'sof ResearchAlabama Hospitalat Birmingham as per the requirements; please note: if a patient is curre [...] he blood sample at a time when the patient's WBC is > 2,000 Myocardial infarction (MI) Ischemic stroke (IS) Avascular necrosis (AVN) Subsequent mal [...] ROLS: Submission of a blood specimen (or in certain cases a buccal cellsaliva specimen) to the ClinicalCoordinating PharmacokineticsCenter Laboratory at St.the JudeUniv [...] [...]
    Show what changed: Study description
    [...] verse events. OUTLINE: DNA and RNA from peripheral blood or buccalsaliva sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.

    Study Status, Study Description, Study Design, Arms and Interventions, Eligibilityv406

  2. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v405

  3. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Eligibility criteria revised; Site details revised at 156 of 156 sites

    Show what changed: Eligibility criteria
    [...] Written informed consent from the patient and/or the patient?'s legally authorized guardian In active follow up by a COG i [...] Written informed consent from the patient and/or the patient?'s legally authorized guardian CONTROLS: In active follow up [...]

    Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv404

  4. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Enrollment target: estimated 8100 to confirmed 3885; Primary completion date changed from estimate of Jan 1, 2100 to Dec 31, 2004; Site details revised at 156 of 156 sites

    Study Status, Conditions, Study Design, Eligibility, Contacts/Locationsv403

  5. Minor

    Study sites: 154 to 156

    Study Status, Contacts/Locationsv402

  6. Minor

    Study sites revised (154)

    Show what changed: Study sites
    NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center PalmettoPrisma Health Richland Hospital University of Vermont and State Agricultural College of Medicine Lady CilentoQueensland Children's Hospital

    Study Status, Contacts/Locationsv401

  7. Minor

    Study sites: 157 to 154

    Study Status, Contacts/Locationsv400

  8. Minor

    Study sites: 155 to 157

    Primary completion date: Jan 2100 to Jan 1, 2100; Start date: Mar 2004 to Mar 22, 2004; Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] Written informed consent from the patient and/or the patient'?s legally authorized guardian In active follow up by a COG i [...] Written informed consent from the patient and/or the patient'?s legally authorized guardian CONTROLS: In active follow up [...]

    Study Identification, Study Status, Oversight, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locationsv399

  9. Minor

    Study sites: 153 to 155

    Study Status, Contacts/Locationsv398

  10. Minor

    3 amendments

    3 re-verifications since 2015-09-30, no change to tracked fields

    v395-v397

  11. Notable

    Primary endpoints: 2 to 3

    Enrollment target: 6900 to 8100; Study sites: 143 to 153; Interventions: laboratory biomarker analysis (Other), questionnaire administration (Other) to Laboratory Biomarker Analysis (Other), Questionnaire Administration (Other); and 3 more

    Show all 7 changes in this update
    • Notable Primary endpoints: 2 to 3
      Show what changed
      Crude disease-exposure
    • Minor Enrollment target: 6900 to 8100
    • Minor Study sites: 143 to 153
    • Minor Interventions: laboratory biomarker analysis (Other), questionnaire administration (Other) to Laboratory Biomarker Analysis (Other), Questionnaire Administration (Other)
    • Minor Eligibility criteria expanded, about 182 words
      Show what changed
      Inclusion Criteria: ELIGIBILITY CRITERIA - CASES Diagnosis of primary cancer at age 21 or younger, irrespecti [...] ollowing initiation of cancer therapy: Cardiac dysfunction; Pleaseplease Notenote: case enrollment has been closed due to achievement of targ [...] bsequent malignant neoplasm (SMN) Avascular necrosis (AVN); Pleaseplease Notenote: case enrollment has been closed due to achievement of targ [...] Jude Children's Research Hospital as per the requirements; Pleaseplease Notenote: if a patient is currently receiving active cancer treatmen [...] ble to obtain the blood sample at a time when the patient's white bl [...] [...]
    • Minor Study description shortened, about 42 words
      Show what changed
      [...] candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls. V. To explore the role and nat [...] teraction in the development of key adverse events. OUTLINE: This is a multicenter study. DNA and RNA from peripheral blood or buccal sample of patients is analy [...] iated with an increased risk of late-occurring complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subseque [...] [...]
    • Minor Study title expanded, about 2 words
      Show what changed
      StudyGenetic ofAnalysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

    Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv394

  12. Minor

    3 amendments

    3 re-verifications since 2014-08-21, no change to tracked fields

    v391-v393

  13. Minor

    Study sites: 139 to 143

    Study Identification, Study Status, Eligibility, Contacts/Locationsv390

  14. Notable

    Primary completion date: Mar 2005 to Jan 2100

    Study sites: 144 to 139; Interventions: cytogenetic analysis (Genetic), mutation analysis (Genetic), polymorphism analysis (Genetic), questionnaire administration (Other) to laboratory biomarker analysis (Other), questionnaire administration (Other); Eligibility criteria shortened, about 137 words; and 2 more

    Show all 6 changes in this update
    • Notable Primary completion date: Mar 2005 to Jan 2100
    • Minor Study sites: 144 to 139
    • Minor Interventions: cytogenetic analysis (Genetic), mutation analysis (Genetic), polymorphism analysis (Genetic), questionnaire administration (Other) to laboratory biomarker analysis (Other), questionnaire administration (Other)
    • Minor Eligibility criteria shortened, about 137 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: Diagnosis of primary cancer at age 21 or younger, irrespective of current age No prior history of allogeneic (non-autologous) hematopoietic cell transplant Development of one of the following key adverse events at any time following initiation of cancer therapy: Cardiac dysfunction; Please Note: case enrollment has been closed due to achievement [...] In active follow- up by a Children's Oncology Group (COG) institution Date; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months Case; group Developm [...] [...]
    • Minor Study description shortened, about 68 words
      Show what changed
      PRIMARY OBJECTIVES: IdentifyI. To identify key late-occurringadverse complications,events specifically,developing cardiacin dysfunctionpatients (closedcases) with a primary cancer diagnosed at age 21 or younger. II. To characterize the key adverse events with respect to accrualthe as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasm, in childhood cancer survivors. Correlate key late-occurring complications with pathology and stagingnature of the primary malignancy (patho [...] [...]
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv389

  15. Minor

    Site contacts updated at 1 of 144 sites

    Study Status, Contacts/Locationsv388

  16. Minor

    Study Status

    Re-verified, no change to tracked fields

    v387

  17. Minor

    Site contacts updated at 1 of 144 sites

    Study Status, Contacts/Locationsv386

  18. Minor

    Study Status

    Re-verified, no change to tracked fields

    v385

  19. Minor

    Study sites revised (144)

    Show what changed: Study sites
    SacredNemours HeartChildren's CancerClinic Center- atPensacola Helen SacredDeVos Heart Hospital ButterworthChildren's Hospital at Spectrum Health

    Study Status, Contacts/Locationsv384

  20. Minor

    Study Status

    Re-verified, no change to tracked fields

    v383

  21. Minor

    Site contacts updated at 1 of 144 sites

    Study Status, Contacts/Locationsv382

  22. Minor

    Site contacts updated at 1 of 144 sites

    Study Status, Contacts/Locationsv381

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v380

  24. Minor

    Study sites: 145 to 144

    Study Status, Contacts/Locationsv379

  25. Minor

    Study Status

    Re-verified, no change to tracked fields

    v378

  26. Minor

    Site contacts updated at 1 of 145 sites

    Study Status, Contacts/Locationsv377

  27. Minor

    Study sites revised (145)

    Show what changed: Study sites
    CaroleConnecticut andChildren's Ray Neag Comprehensive CancerMedical Center at the University of Connecticut Health Center

    Study Status, Contacts/Locationsv376

  28. Minor

    Study Status

    Re-verified, no change to tracked fields

    v375

  29. Minor

    Study sites: 131 to 145

    Study Status, Contacts/Locationsv374

  30. Minor

    Study sites revised (131)

    Show what changed: Study sites
    Children's Hospital of Pittsburgh of UPMC

    Study Status, Contacts/Locationsv373

  31. Minor

    Study Status

    Re-verified, no change to tracked fields

    v372

  32. Minor

    Study sites revised (131)

    Show what changed: Study sites
    Dayton Children's Medical Center - Dayton

    Study Status, Contacts/Locationsv371

  33. Minor

    Study Status

    Re-verified, no change to tracked fields

    v370

  34. Minor

    Site contacts updated at 1 of 131 sites

    Study Status, Contacts/Locationsv369

  35. Minor

    Site contacts updated at 1 of 131 sites

    Study Status, Contacts/Locationsv368

  36. Minor

    Site contacts updated at 1 of 131 sites

    Study Status, Contacts/Locationsv367

  37. Minor

    Study sites: 129 to 131

    Study Status, Contacts/Locationsv366

  38. Minor

    Study sites: 127 to 129

    Study Status, Contacts/Locationsv365

  39. Minor

    Study sites: 126 to 127

    Study Status, Contacts/Locationsv364

  • 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.
This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
Trial Details
NCT Number NCT00082745
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Childhood Malignant Neoplasm
Enrollment 3,885 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov