ALTE05N1, Umbrella Long-Term Follow-up Protocol

Study ID
STU 072011-021

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
William Thurman
214-456-6439
jacob.thurman@childrens.com

Principal Investigator
Naomi Winick

Summary

The Long Term Follow-up Center (LTFC), located in the Keck School of Medicine[Right Quote]s Department of Preventive Medicine at the University of Southern California, was established in order to develop a costeffective mechanism for tracking and maintaining contact with patients enrolled on ALTE05N1. The LTFC will perform regular follow-up with patients utilizing a variety of techniques to maintain currency of contact information, and will employ other available resources to re-establish contact with patients (or their parents) when contact has been lost. The LTFC will maintain up-to-date demographic and self/parent-reported health status information on each patient and will provide updated data to the SDC on a regular basis, and the SDC will subsequently forward this information to each patient[Right Quote]s COG institution, after obtaining permission from the participant. This updated information will assist COG institutions in conducting follow-up examinations and collecting protocol-specific data. In addition, cumulative therapeutic exposure information will be entered into a central database. These data can then be linked with patient outcomes, facilitating identification of important associations and concerns for outcomes research.

Participant Eligibility

The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy and is nearing completion of or has recently completed protocol treatment (within the past 180 days);
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