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Trial record 1 of 1 for:    ALTE05N1
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Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

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ClinicalTrials.gov Identifier: NCT00736749
Recruitment Status : Recruiting
First Posted : August 18, 2008
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date August 15, 2008
First Posted Date August 18, 2008
Last Update Posted Date September 18, 2020
Actual Study Start Date May 19, 2008
Estimated Primary Completion Date January 31, 2100   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
  • Percentage of patients enrolled [ Time Frame: Up to 20 years ]
  • Percentage of patients in which long-term (20+ years) contact is maintained [ Time Frame: Up to 20 years ]
  • Percentage of eligible patients located who were lost to follow-up [ Time Frame: Up to 20 years ]
  • Percentage of located patients enrolled [ Time Frame: Up to 20 years ]
    Differences between participants and non-participants will be examined annually, in terms of demographic (age, sex, ethnicity) and clinical characteristics (primary diagnosis, therapeutic protocol, time since diagnosis, treating institution).
  • Collection of protocol-specific outcome data [ Time Frame: Up to 20 years ]
    Methods of statistical analysis to be used are those appropriate for analysis of cohort studies. Poisson regression (piece-wise exponential models) and Cox regression will be the primary methods of risk-factor analysis. When comparing study cohort with national rates, Poisson regression will be used. When the comparison is internal (ie, no use of national standard rates), Cox regression will be used.
  • Collection of cumulative therapeutic exposure data [ Time Frame: Up to 20 years ]
Original Primary Outcome Measures
 (submitted: August 15, 2008)
  • Development of mechanism for tracking and retaining patients enrolled on COG protocols
  • Maintenance of regular, lifetime contact with patients
  • Location of targeted patients lost to follow up
  • Current patient contact information and reported health status updates
  • Collection of protocol-specific outcome data
  • Collection of cumulative therapeutic exposure data
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Official Title Umbrella Long-Term Follow-Up Protocol
Brief Summary This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.
Detailed Description

PRIMARY OBJECTIVES:

I. To develop a mechanism for tracking and retaining patients enrolled on Children's Oncology Group (COG) protocols.

II. To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status.

III. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC).

IV. To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution.

V. To facilitate collection of protocol-specific outcome data through collaboration with the LTFC Oversight Committee, the SDC, and the member institutions.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Within 3 months of enrollment on ALTE05N1, patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Acute Lymphoblastic Leukemia
  • Brain Neoplasm
  • Hematopoietic Cell Transplantation Recipient
  • Hodgkin Lymphoma
  • Osteosarcoma
  • Rhabdomyosarcoma
Intervention
  • Procedure: Assessment of Therapy Complications
    Complete patient response form and Health Status Update Form
  • Other: Questionnaire Administration
    Complete patient response form and Health Status Update Form
Study Groups/Cohorts Observational (long-term follow-up)
Within 3 months of enrollment of ALTE05N1, patients receive a mailed packet introducing the LTFC. Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.
Interventions:
  • Procedure: Assessment of Therapy Complications
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 3, 2018)
4738
Original Estimated Enrollment
 (submitted: August 15, 2008)
906
Study Completion Date Not Provided
Estimated Primary Completion Date January 31, 2100   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy;or the patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1

    • Hodgkin lymphoma

      • CCG 5942
      • POG 9425
      • POG 9426
      • AHOD0031
      • AHOD1331
      • S1826 (COG patients only)
    • Brain tumor

      • A9961
    • Acute lymphoblastic leukemia

      • POG 9404
    • Osteosarcoma

      • POG 9754
    • Stem cell transplantation

      • ASCT0631D
    • Rhabdomyosarcoma

      • IRS-III
      • IRS-IV
    • Late Effects Protocols with Patients Eligible for Enrollment on ALTE05N1

      • ALTE15N1
      • ALTE16C1
    • Enrollment on ALTE05N1 must occur within 24 calendar months of the date the patient was enrolled on a frontline COG therapeutic trial; or patients previously enrolled on a COG (or Legacy Group) trial targeted for long term follow-up by ALTE05N1 may enroll on ALTE05N1 at any time
  • The patient must reside in the U.S. on the date of enrollment to ALTE05N1
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00736749
Other Study ID Numbers ALTE05N1
NCI-2009-00382 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PALTE05N1_A06PAMDREVW01
CDR0000590123
ALTE05N1 ( Other Identifier: Childrens Oncology Group )
ALTE05N1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Smita Bhatia Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date September 2020