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

Children's Oncology Group

Status: Enrolling

Conditions: Solid Tumor; Leukemia; Hematopoietic Cell Transplantation Recipient

Treatments: Other: Questionnaire Administration; Procedure: Assessment of Therapy Complications

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00736749

U10CA180886 (U.S. NIH Grant/Contract)

UG1CA189955 (U.S. NIH Grant/Contract)

U10CA098543 (U.S. NIH Grant/Contract)

ALTE05N1 (Other Identifier)

NCI-2009-00382 (Registry Identifier)

UG1CA189958 (U.S. NIH Grant/Contract)

CDR0000590123

PALTE05N1_A06PAMDREVW01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

5,000 participants in 1 patient group

Observational (long-term follow-up)

Description:

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

Treatment:

Procedure: Assessment of Therapy Complications

Other: Questionnaire Administration