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

• ClinicalTrials.gov Identifier: NCT00736749
• Recruitment Status: Recruiting
• First Posted: August 18, 2008
• Last Update Posted: September 18, 2020
• Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Children's Oncology Group

Tracking Information

• First Submitted Date: August 15, 2008
• First Posted Date: August 18, 2008
• Last Update Posted Date: September 18, 2020
• Actual Study Start Date: May 19, 2008
• Estimated Primary Completion Date: January 31, 2100 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2018)

• Percentage of patients enrolled [ Time Frame: Up to 20 years ]
• Percentage of patients in which long-term (20+ years) contact is maintained [ Time Frame: Up to 20 years ]
• Percentage of eligible patients located who were lost to follow-up [ Time Frame: Up to 20 years ]
• 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).
• 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.
• Collection of cumulative therapeutic exposure data [ Time Frame: Up to 20 years ]

Original Primary Outcome Measures (submitted: August 15, 2008)

• Development of mechanism for tracking and retaining patients enrolled on COG protocols
• Maintenance of regular, lifetime contact with patients
• Location of targeted patients lost to follow up
• Current patient contact information and reported health status updates
• Collection of protocol-specific outcome data
• Collection of cumulative therapeutic exposure data

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
• Official Title: Umbrella Long-Term Follow-Up Protocol
• 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 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 Type: Observational
• Study Design: Not Provided
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Not Provided

Condition

• Acute Lymphoblastic Leukemia
• Brain Neoplasm
• Hematopoietic Cell Transplantation Recipient
• Hodgkin Lymphoma
• Osteosarcoma
• Rhabdomyosarcoma

Intervention

• 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

Study Groups/Cohorts

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.

Interventions:

• Procedure: Assessment of Therapy Complications
• Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2018): 4738
• Original Estimated Enrollment (submitted: August 15, 2008): 906
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: January 31, 2100 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
    • AHOD0031
    • AHOD1331
    • S1826 (COG patients only)

  • Brain tumor

    • A9961

  • Acute lymphoblastic leukemia

    • POG 9404

  • Osteosarcoma

    • POG 9754

  • Stem cell transplantation

    • ASCT0631D

  • Rhabdomyosarcoma

    • IRS-III
    • IRS-IV

  • Late Effects Protocols with Patients Eligible for Enrollment on ALTE05N1

    • ALTE15N1
    • ALTE16C1
  • 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Children's Oncology Group
• Study Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Smita Bhatia; Children's Oncology Group

• PRS Account: Children's Oncology Group
• Verification Date: September 2020