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

Study Description

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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.

Condition or disease	Intervention/treatment
Acute Lymphoblastic Leukemia; Brain Neoplasm; Hodgkin Lymphoma; Rhabdomyosarcoma	Procedure: Assessment of Therapy Complications; Other: Questionnaire Administration

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	4485 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Umbrella Long-Term Follow-Up Protocol
Study Start Date :	May 2008
Estimated Primary Completion Date :	January 2100

Groups and Cohorts

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Group/Cohort

Intervention/treatment

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

Outcome Measures

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Primary Outcome Measures :

1. Collection of cumulative therapeutic exposure data [ Time Frame: Up to 20 years ]
2. 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.
3. Percentage of eligible patients located who were lost to follow-up [ Time Frame: Up to 20 years ]
4. 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).
5. Percentage of patients enrolled [ Time Frame: Up to 20 years ]
6. Percentage of patients in which long-term (20+ years) contact is maintained [ Time Frame: Up to 20 years ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT00736749 History of Changes
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 )
First Posted:	August 18, 2008
Last Update Posted:	October 23, 2017
Last Verified:	October 2017

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