Biorepository Process

Standard Procedure

  1. Rationale and significance study: Pediatric Cancer is a leading cause of death in the pediatric population worldwide. We will collect tumor tissue from all patients going to the OR at Rady Children's Hospital for initial resection and at relapse if medically indicated.
  2. Method of consent (subtype SOP Template #1): Consent will be obtained at the patients first encounter for tissues left over after diagnostic material has been obtained as determined by PA and attending pathologist of record for each case.
  3. Methods for tissue collection and transport: The Pathologist Assistant (PA) will interface with the attending pathologist responsible for the case and the Clinical Research Coordinator (CRC) associated with Tissue Bank and with Clinical Research Coordinator in the Division of Hematology-Oncology to identify potential patients and to plan for acquisition of excess tissue samples which are available following careful consideration to obtain tissue for primary diagnostic evaluations.
  4. Clinical Data fields to collect prior to de-identification: Primary oncologic diagnosis, demographics, stage, grade, associated biological markers, prognostic category, planned treatment, size and location of tumor mass
  5. Methods for de-identification: specimen will remain in CLIA/CAP certified system an extension of clinical pathology department. All data released to researchers applying for tissue from the Tissue Bank will be de-identified.
  6. Methods for re-identification (optional)(requires separate IRB unless type 2 protocol): not applicable, specimens will remain in CLIA/CAP certified environment.
  7. Biostatistical considerations (sample size, power determinations): To be determined based on specific assays to be performed.
  8. Associated Studies (COG or other cooperative group studies utilize same tissue): To be entered by associated CRC.
  9. Contact personnel (related to this study): (Division, phone and pager numbers)
  10. Regulatory issues (IRB)
  11. Biosafety considerations (sample size, power determinations): To be determined based on specific assays to be performed.
  12. References: Not applicable for general collection protocol.