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

  • STATUS
    Recruiting
  • participants needed
    4738
  • sponsor
    Children's Oncology Group
Updated on 23 September 2020
Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (7.7 mi away) Contact
+100 other location
cancer
lymphoid leukemia
lymphoma
hodgkin's disease
cell transplantation
leukemia
brain tumor

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.

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.

Details
Treatment questionnaire administration, Assessment of Therapy Complications
Clinical Study IdentifierNCT00736749
SponsorChildren's Oncology Group
Last Modified on23 September 2020

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Eligibility

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Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Sarcoma or Osteosarcoma or Sarcoma (Pediatric) or Brain Tumor or Malignant neoplasm of brain or Rhabdomyosarcoma or childhood ALL or Soft Tissue Sarco...?
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
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