Childhood Cancer Survivor Study Expansion: Long-Term Follow-up Study
The University of Texas Southwestern (UTSW) will only be involved in the identification of potential subjects, sending out the initial contact letters and completing medical record abstraction for consented subjects via the Coordinating Center, housed at St. Jude Children's Research Hospital (SJCRH). The first contact letter will introduce the study to the patient and request permission to send personal contact information and medical record information to the CCSS Coordinating Center via a HIPAA authorization form. Alteration of the HIPAA authorization requirements of documentation will allow a verbal consent process over the phone and/or by mail with the participants returning a signed document only if desired. St. Jude's Long Term Followup Study team will provide oral instruction by telephone to fully explain the procedures to obtain a HIPAA authorization with a waiver of signature documentation. Other standard procedures will remain the same.
In addition, the initial contact letters will explain that subjects may respond in 4 ways: 1) by visiting the Long Term Follow-up Study website where they can learn more information and sign the HIPAA authorization form electronically; 2) by returning the paper form, to receive a paper recruitment packet; 3) by sending an email to ask questions that LTFC staff will respond to by the most appropriate means; or, 4) by telephoning the LTFC toll-free number to speak directly with a LTFC staffer, who will respond to questions and provide information about the study.
Subjects within the expanded CCSS population will complete two surveys during the proposed funding period, consisting of a baseline questionnaire (a modification of the survey used in the initial 1970-86 study population) and a follow-up survey designed specifically for the expanded population.
The patient's medical record will be abstracted using the Medical Record Abstraction Form (MRAF) used in the initial cohort via a newly designed web-based system. This web-based system will be secure and only accessible to the appropriate personnel. The data will be collected, transmitted, stored and used in accordance with confidentiality protections.
In order to study the etiology and underlying biology of long-term effects of exposure to cancer therapy, participants will be asked to submit buccal cell (cheek cells) samples, using the mouthwash method for buccal cell collection. This will require a separate consent obtained by St. Jude Children's Research Hospital via the mail.
The expanded study may request a blood sample collection of 40 ml from patients diagnosed with a second malignancy or who are at high risk for second malignancy. Only a small proportion of study subjects will be involved in this aspect of the study. The blood will be sent to the CCSS laboratory in Cincinnati for processing and storage. In addition, a request for Paraffin block(s) containing the subsequent malignant neoplasm (SMN) will be made. SJCRH will obtain consent for all blood, buccal and Paraffin block requests
If a participant identifies an eligible sibling, a letter will be sent to the sibling inviting their participation in CCSS. If the siblings agree to participate, a specific baseline questionnaire will need to be completed and returned to the Coordinating Center at St. Jude Children's Research Hospital. Siblings will also be asked to submit a buccal cell sample.
In addition, Spanish speaking patients will be eligible to participate with the use of a translated Spanish contact letter, consent and questionnaire.
1) Have a diagnosis of one of the following: leukemia, ependymomas, medulloblastoma/PNET, cortical/cerebral/diencephalic/gliomas/astrocytoma (including mixed gliomas), Non-Hodgkins Lymphoma, Hodgkins Disease, neuroblastoma, Wilms' tumor, Rhabdomyosarcoma, Osteosarcoma, Ewings Disease;
2) Less than 21 years of age at time of diagnosis;
3) Diagnosed between 1987 and 1999;
4)Alive 5 years or more from date of diagnosis;
5) Must be diagnosed and treated at a participating CCSS center;
6)English- or Spanish-speaking
There are no inclusion/exclusion criteria for sibling participants, other than full sibling closest in age to identified survivor.