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Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Children's Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00736749
First received: August 15, 2008
Last updated: April 8, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Acute Lymphoblastic Leukemia
Brain Neoplasm
Hodgkin Lymphoma
Rhabdomyosarcoma
Procedure: Assessment of Therapy Complications
Other: Questionnaire Administration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Umbrella Long-Term Follow-Up Protocol

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Collection of cumulative therapeutic exposure data [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
  • Collection of protocol-specific outcome data [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of eligible patients located who were lost to follow-up [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
  • Percentage of located patients enrolled [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
    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).

  • Percentage of patients enrolled [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
  • Percentage of patients in which long-term (20+ years) contact is maintained [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4485
Study Start Date: May 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (long-term follow-up)
Approximately 6 months after completion of therapy patients receive a mailed packet introducing the LTFC and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. 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 receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.
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

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 COG Late Effects Committee, the SDC, and the member institutions.

VI. To collect cumulative therapeutic exposure data (via therapeutic summaries completed online by treating institutions) on patients completing active therapy.

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

Approximately 6 months after completion of therapy patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC) and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. 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 receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Hodgkin lymphoma enrolled on CCG-5942, POG-9425, POG-9426, COG-AHOD0031; patients with brain tumors enrolled on CCG-A9961; patients with acute lymphoblastic leukemia enrolled on POG-9404; patients with rhabdomyosarcoma
Criteria

Inclusion Criteria:

  • The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy and is nearing completion of or has recently completed protocol treatment (within the past 180 days)*; 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
      • COG-AHOD0031
    • Brain tumor

      • CCG-A9961
    • Acute lymphoblastic leukemia

      • POG-9404
    • Rhabdomyosarcoma

      • IRS-III
      • IRS-IV
    • Note: For purposes of enrollment onto this study, completion of treatment is defined as the date protocol therapy was terminated as reported (or will be reported) on this patient's last "Reporting Period Worksheet/CRF" for their frontline therapeutic protocol; patients become eligible as they approach this date, and remain eligible for 180 days following the date that protocol therapy was terminated; early termination of protocol therapy per the decision of the patient, family and/or investigator does NOT preclude enrollment on this study
    • Note: For purposes of eligibility for ALTE05N1, "early termination of protocol therapy" means that the patient has finished protocol therapy and will not receive further treatment; patients whose therapy is terminated early due to toxicity or who opt out of an end-of-therapy randomization (e.g., randomization to continue with an experimental agent vs. no further treatment) are eligible because they will not be receiving further therapy; however, a patient who is removed from protocol therapy or opts to discontinue protocol participation early in the course of treatment (e.g., following Induction) is not eligible
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736749

  Show 162 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Smita Bhatia Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00736749     History of Changes
Other Study ID Numbers: ALTE05N1  NCI-2009-00382  PALTE05N1_A06PAMDREVW01  CDR0000590123  ALTE05N1  ALTE05N1  U10CA180886  U10CA098543 
Study First Received: August 15, 2008
Last Updated: April 8, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Hodgkin Disease
Rhabdomyosarcoma
Brain Neoplasms
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 30, 2016