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

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00736749
First received: August 15, 2008
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.


Condition Intervention
Accelerated Phase Chronic Myelogenous Leukemia
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
Acute Undifferentiated Leukemia
Angioimmunoblastic T-cell Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Grade III Lymphomatoid Granulomatosis
Childhood Immunoblastic Large Cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
Essential Thrombocythemia
Extramedullary Plasmacytoma
Intraocular Lymphoma
Isolated Plasmacytoma of Bone
Juvenile Myelomonocytic Leukemia
Long-term Effects Secondary to Cancer Therapy in Children
Mast Cell Leukemia
Meningeal Chronic Myelogenous Leukemia
Monoclonal Gammopathy of Undetermined Significance
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Polycythemia Vera
Post-transplant Lymphoproliferative Disorder
Primary Central Nervous System Hodgkin Lymphoma
Primary Central Nervous System Non-Hodgkin Lymphoma
Primary Myelofibrosis
Primary Systemic Amyloidosis
Progressive Hairy Cell Leukemia, Initial Treatment
Prolymphocytic Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Stage 0 Chronic Lymphocytic Leukemia
Stage I Childhood Anaplastic Large Cell Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage I Childhood Large Cell Lymphoma
Stage I Childhood Lymphoblastic Lymphoma
Stage I Childhood Small Noncleaved Cell Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Multiple Myeloma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage II Childhood Anaplastic Large Cell Lymphoma
Stage II Childhood Hodgkin Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage II Childhood Lymphoblastic Lymphoma
Stage II Childhood Small Noncleaved Cell Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Multiple Myeloma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Childhood Anaplastic Large Cell Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage III Childhood Large Cell Lymphoma
Stage III Childhood Lymphoblastic Lymphoma
Stage III Childhood Small Noncleaved Cell Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Multiple Myeloma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage IV Childhood Anaplastic Large Cell Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Stage IV Childhood Large Cell Lymphoma
Stage IV Childhood Lymphoblastic Lymphoma
Stage IV Childhood Small Noncleaved Cell Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
T-cell Large Granular Lymphocyte Leukemia
Unspecified Childhood Solid Tumor, Protocol Specific
Untreated Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Untreated Hairy Cell Leukemia
Waldenström Macroglobulinemia
Other: survey administration
Procedure: assessment of therapy complications
Procedure: long-term screening
Procedure: study of high risk factors

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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Multiple Myeloma Chronic Myeloproliferative Disorders Acute Lymphoblastic Leukemia Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Hodgkin Lymphoma, Childhood B-cell Lymphomas Myelofibrosis Juvenile Myelomonocytic Leukemia Burkitt Lymphoma Lymphoma, Large-cell Lymphomatoid Granulomatosis Lymphoma, Large-cell, Immunoblastic Lymphoblastic Lymphoma Small Non-cleaved Cell Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Acute Lymphoblastic Leukemia, Childhood Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Acute Myeloid Leukemia, Childhood Monoclonal Gammopathy of Undetermined Significance Cutaneous T-cell Lymphoma AL Amyloidosis Essential Thrombocythemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Large Granular Lymphocyte Leukemia Anaplastic Plasmacytoma Polycythemia Vera Systemic Mastocytosis Mastocytosis
U.S. FDA Resources

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

Primary Outcome Measures:
  • Development of mechanism for tracking and retaining patients enrolled on COG protocols [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Maintenance of regular, lifetime contact with patients [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Location of targeted patients lost to follow up [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Current patient contact information and reported health status updates [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Collection of protocol-specific outcome data [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
  • Collection of cumulative therapeutic exposure data [ Time Frame: Not Provided ] [ Designated as safety issue: No ]

Estimated Enrollment: 906
Study Start Date: May 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm I
See detailed description.
Other: survey administration
Written Survey
Other Name: collection of protocol-specific outcome data
Procedure: assessment of therapy complications Procedure: long-term screening Procedure: study of high risk factors

Detailed Description:

OBJECTIVES:

I. To develop a mechanism for tracking and retaining patients enrolled on 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.

  Eligibility

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 COG-A3973; patients with rhabdomyosarcoma

Criteria

Inclusion Criteria:

  • Must be newly diagnosed with a primary malignancy and enrolled on a front line COG therapeutic trial for treatment of a primary malignancy OR must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial calling for long-term follow-up, including any of the following:

    • Hodgkin lymphoma

      • CCG-5942
      • POG-9425
      • POG-9426
      • COG-AHOD0031
    • Brain tumor

      • CCG-A9961
    • Acute lymphoblastic leukemia

      • COG-ALTE02C2
    • Neuroblastoma

      • COG-A3973
    • Rhabdomyosarcoma

      • IRS-III
      • IRS-IV-Stage 1
      • IRS-IV-Stage 2/3
      • IRS-IV-Stage/Group 4
  • Must reside in the U.S. during trial enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736749

  Show 136 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Smita Bhatia Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00736749     History of Changes
Other Study ID Numbers: ALTE05N1, NCI-2009-00382, CDR0000590123, U10CA098543, COG-ALTE05N1
Study First Received: August 15, 2008
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Primary Myelofibrosis
Amyloidosis
Blast Crisis
Burkitt Lymphoma
Neoplasms
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Hairy Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Mast-Cell
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myelomonocytic, Chronic
Leukemia, Neutrophilic, Chronic
Leukemia, Prolymphocytic
Lymphoma
Lymphoma, Non-Hodgkin
Lymphomatoid Granulomatosis
Lymphoproliferative Disorders
Waldenstrom Macroglobulinemia
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on April 21, 2014