Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
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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 |
- 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 |
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
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00736749
Show 136 Study Locations
| 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: | August 5, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Blast Crisis Burkitt Lymphoma Down Syndrome Hodgkin Disease Hypereosinophilic Syndrome Immunoblastic Lymphadenopathy Intraocular Lymphoma Leukemia Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase |
Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemoid Reaction Lymphoma, B-Cell Lymphoma, Extranodal NK-T-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on March 03, 2015