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.
Brief Title
Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
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.
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.
Conditions
Hematopoietic Cell Transplantation Recipient
Leukemia
Solid Tumor
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT00736749
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
ALTE05N1
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Umbrella Long-Term Follow-Up Protocol
Primary Outcomes
Outcome Measure
Percentage of patients enrolled
Outcome Time Frame
Up to 20 years
Outcome Measure
Percentage of patients in which long-term (20+ years) contact is maintained
Outcome Time Frame
Up to 20 years
Outcome Measure
Percentage of eligible patients located who were lost to follow-up
Outcome Time Frame
Up to 20 years
Outcome Description
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).
Outcome Measure
Percentage of located patients enrolled
Outcome Time Frame
Up to 20 years
Outcome Description
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.
Outcome Measure
Collection of protocol-specific outcome data
Outcome Time Frame
Up to 20 years
Outcome Measure
Collection of cumulative therapeutic exposure data
Outcome Time Frame
Up to 20 years
Secondary Ids
Secondary Id
NCI-2009-00382
Secondary Id
PALTE05N1_A06PAMDREVW01
Secondary Id
CDR0000590123
Secondary Id
ALTE05N1
Secondary Id
ALTE05N1
Secondary Id
U10CA180886
Secondary Id
U10CA098543
Secondary Id
UG1CA189955
Secondary Id
UG1CA189958
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alice Lee
Investigator Email
alee5@montefiore.org