9442: National Wilms Tumor Late Effects Study

Study ID
STU 032011-024

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Michelle Rivas
214-456-0004
michelle.rivas@childrens.com

Principal Investigator
Jonathan Wickiser

Summary

* a Physical examination Form will be completed by the patient's physician every five years from the time of diagnosis.
* a Status Report will be completed each year.
* Questionnaires for mothers (about pregnancies and births) will be completed for each pregnancy or birth.
* There will be requests for additional information about serious health experiences that patients may have in the future or about other family members who develop a cancer.

This research study involves the completion of the above mentioned forms which require information about subject's family and subject's current state of health. Depending upon subject's health status, subjects may also be asked to allow copies of subjects medical records (to evaluate complications of previous treatment, childbirth, the occurrence of new medical conditions), and medical records regarding the birth and medical conditions of subject's children to be sent to the nWTS Data and Statistical Center. This study does not specifically involve obtaining any blood tests.

Participant Eligibility


3.1 NWTS-1 through NWTS-4: Registration procedures for entry onto NWTS-1 through NWTS-4 included obtaining written consent from the patient's parents for participation in the study, including collection of follow-up data for an indefinite period. These patients were automatically eligible for the Late Effects Study when they reached their second anniversary following diagnosis. There was no separate consent or registration for these patients.
3.2 NWTS-5: Institutions should complete and submit a Participant Entry Questionnaire (PEQ). See below. If the institution's original consent allowed for long term follow-up, the institution need merely notify the Data and Statistical Center (DSC) that their patients are consented. Starting with the 9/01 revision of the protocol, NWTS-5 patients can be reconsented and thus registered on the Late Effects Study. Do not report the registration using the COG RDE. At the time the institution informs the DSC of a newly consented patient it should also report the date of contact, the method of contact, and the status of the patient[Single Quote]s health. The DSC can then code a new date of follow-up which will be included in the report to COG. The DSC will report to COG quarterly.

NWTS-5 patients are eligible if they:

3.21 Were registered as a Studied or Followed patient on NWTS-5;

3.22 Were <16 years of age at the time of diagnosis of a stage I-V favorable histology Wilms tumor, stage I-V focal or diffuse, anaplastic Wilms tumor, stage I-V clear cell sarcoma of the kidney (CCSK) or stage I - V rhabdoid tumor of the kidney (RTK), including those tumors with any of the above histologies which occurred in fused (horseshoe or discoid) kidneys, or a solitary kidney, or at an extra-renal site

3.23 Survived for two years after diagnosis.