Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
- Conditions
- Hematopoietic Cell Transplantation RecipientLeukemiaSolid Tumor
- Registration Number
- NCT00736749
- Lead Sponsor
- Children's Oncology Group
- 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.
- 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 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.
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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection of cumulative therapeutic exposure data Up to 20 years Collection of protocol-specific outcome data 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.
Percentage of patients in which long-term (20+ years) contact is maintained Up to 20 years Percentage of patients enrolled Up to 20 years Percentage of located patients enrolled 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).
Percentage of eligible patients located who were lost to follow-up Up to 20 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (164)
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
USA Health Strada Patient Care Center
🇺🇸Mobile, Alabama, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
The University of Arizona Medical Center-University Campus
🇺🇸Tucson, Arizona, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
🇺🇸Downey, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Scroll for more (154 remaining)Children's Hospital of Alabama🇺🇸Birmingham, Alabama, United States