Umbrella Long-Term Follow-Up Protocol
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 LTFC Oversight Committee, the SDC, and the member institutions.
OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.
Within 3 months of enrollment on ALTE05N1, patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. 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 may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.
Accepting Healthy Volunteers?
- The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy;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
- S1826 (COG patients only)
- Brain tumor
- Acute lymphoblastic leukemia
- POG 9404
- POG 9754
- Stem cell transplantation
- Late Effects Protocols with Patients Eligible for Enrollment on ALTE05N1
- Enrollment on ALTE05N1 must occur within 24 calendar months of the date the patient was enrolled on a frontline COG therapeutic trial; or patients previously enrolled on a COG (or Legacy Group) trial targeted for long term follow-up by ALTE05N1 may enroll on ALTE05N1 at any time
- 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