Summary

Location
at Los Angeles, California and other locations
Dates
study started
Principal Investigator
by William A. May

Description

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.

Official Title

Umbrella Long-Term Follow-Up Protocol

Details

PRIMARY OBJECTIVES:

  1. 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 quality of life and 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.

  1. 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 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, secure online form, or 24-hour toll-free telephone number. After initial contact, the LTFC will contact the patient annually.

Keywords

Hematopoietic Cell Transplantation Recipient, Leukemia, Solid Tumor, Assessment of Therapy Complications

Eligibility

Inclusion Criteria:

  • 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

Locations

  • Mattel Children's Hospital UCLA accepting new patients
    Los Angeles California 90095 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Kaiser Permanente Downey Medical Center accepting new patients
    Downey California 90242 United States
  • Miller Children's and Women's Hospital Long Beach accepting new patients
    Long Beach California 90806 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Sponsor
Children's Oncology Group
Links
Sign up for this study
ID
NCT00736749
Study Type
Observational
Participants
Expecting 5000 study participants
Last Updated