ALTE05N1, Umbrella Long-Term Follow-up Protocol

Study ID
STU 072011-021

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Beverly Kleiber
214-456-6484
beverly.kleiber@childrens.com

Principal Investigator
Patrick Leavey

Summary

The Long Term Follow-up Center (LTFC), located in the Keck School of Medicine'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'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