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Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736749
Recruitment Status : Recruiting
First Posted : August 18, 2008
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Brain Neoplasm Hematopoietic Cell Transplantation Recipient Hodgkin Lymphoma Osteosarcoma Rhabdomyosarcoma Procedure: Assessment of Therapy Complications Other: Questionnaire Administration

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 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 4738 participants
Official Title: Umbrella Long-Term Follow-Up Protocol
Actual Study Start Date : May 19, 2008
Estimated Primary Completion Date : January 31, 2100

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (long-term follow-up)
Within 3 months of enrollment of ALTE05N1, patients receive a mailed packet introducing the 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.
 Procedure: Assessment of Therapy Complications
Complete patient response form and Health Status Update Form

Other: Questionnaire Administration
Complete patient response form and Health Status Update Form


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients enrolled [ Time Frame: Up to 20 years ]
  2. Percentage of patients in which long-term (20+ years) contact is maintained [ Time Frame: Up to 20 years ]
  3. Percentage of eligible patients located who were lost to follow-up [ Time Frame: Up to 20 years ]
  4. Percentage of located patients enrolled [ Time Frame: 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).

  5. Collection of protocol-specific outcome data [ Time Frame: 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.

  6. Collection of cumulative therapeutic exposure data [ Time Frame: Up to 20 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736749


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Smita Bhatia Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00736749    
Other Study ID Numbers: ALTE05N1
NCI-2009-00382 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PALTE05N1_A06PAMDREVW01
CDR0000590123
ALTE05N1 ( Other Identifier: Childrens Oncology Group )
ALTE05N1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Osteosarcoma
Rhabdomyosarcoma
Brain Neoplasms
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases