Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Trial Purpose and Description
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.
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.
- N/A - N/A
- 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
- Brain tumor
- Acute lymphoblastic leukemia
- IRS-IV-Stage 1
- IRS-IV-Stage 2/3
- IRS-IV-Stage/Group 4
- 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
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
- Children's Oncology Group
- National Cancer Institute (NCI)
- May 2008
- Last Updated:
- March 18, 2015
- Study HIC#:
Clinicaltrials.gov ID: NCT00736749