Current status of disease registry and prospective observational study—Pediatric hematological malignancy—

Abstract

To improve the treatment outcome and QOL of patients with pediatric hematological malignancy in Japan, the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG; now Japanese Children’s Cancer Group (JCCG)) was established in 2003. Registration and the central laboratory/diagnosis systems under the CHM-14 study have been used for all patients enrolled in clinical trials by JCCG. On the other hand, since 2006, epidemiological research on pediatric hematological diseases were started by the Japanese Society of Pediatric Hematology (now the Japanese Society of Pediatric Hematology/Oncology (JSPHO)) in 2006. Data on the current status of these patients, including their background, diagnosis, and outcome, have been collected under “Epidemiological research on hematological diseases and pediatric cancers developing in patients under 20 years of age” by the academic research committee of JSPHO. Compartmentalization of both studies has been carried out; that is, the collection of the annual number and outcome of the patients has been carried out by JSPHO, and the accurate diagnosis, assessment of the efficacy and safety of clinical studies, and research on sample analysis have been conducted by JCCG. A convenient method for the collection of overlapping data in both studies has been developed. However, the challenge lies in how to effectively reduce the effort involved in data entry. because of the annual accumulation of follow-up cases.