A patient registry collects and stores patient medical information, family history and other related information for use in medical research. The purpose of the HCC leukemia registry is to collect and store medical and other information (epidemiologic data, treatment information and long-term outcome as well as quality of life) from patients with acute leukemia. There is very limited large registry based data that is available from India. The objective of this exercise is to initiate a process by which well annotated clinical data base will be maintained prospectively. This will be useful for analysis of trends in diagnosis and treatment. The ultimate objective is to steadily improve the delivery of treatment for patients with acute leukemia in the country. 

The registry will have both prospective and retrospective components. The retrospective data will be from 2012 till the IEC approval because the clinical information system has been operational at our centre from 2011, hence it is possible to obtain complete data from which 3-year survival statistics can be obtained. The prospective registry will start from the date of ethics committee approval.

This study is non interventional and the treatment of all patients participating will be carried out within clinical routine, at the discretion of the physician based on existing guidelines. The patients who are equal to or more than 15 years of age and are newly diagnosed with leukemia, will be enrolled in the study if they give an informed consent.There is no specification on the total number of subjects to be enrolled as this is a registry.

An important part of the registry is the collection and storage of bone marrow and peripheral blood samples in a biomaterial database. For the preservation of biomaterials, the patient has to agree separately to the removal, transfer of ownership and preservation of biomaterial. The removal of biomaterial is part of the standard procedure; hence additional collections is not necessary. The biomaterial database should be an opportunity for scientists to access biomaterial for leukemia related research projects in the future.

Quality of life questionnaires will be given to the patients. For the collection of quality of life questionnaire FACT-Leu will be used.  QOL will be administered at initial diagnosis, end of treatment and once a year during a 3-year follow-up

The initial centers for the study are TMH, Mumbai and CMC, Vellore. Additional centers and members will join and be listed out as they do.

 The documentation of the data is via an online data capture program. This will need to be accessed and entered by the individual center. It will be the responsibility of the individual center to maintain the source documents – hard and electronic as applicable. At the initial diagnosis, a relevant patient history will be recorded including leukemia related parameters. At the follow-up visit (follow up interval as per the center’s discretion) events between the previous follow-up visit and the present visit will be recorded. If the patient is not available for an on-site visit, the follow-up contacts can be performed via telephone with the attending doctor or hematologist. In the CRF, each individual patient dataset will be denoted by a unique identification number, comprised of the site number and the consecutive patient number. By giving informed consent the patient will agree to the fact that the physician will collect the data for this registry from the initial diagnosis of acute leukemia as well as the data for the following visits up to the follow-up visits.The registry file will be stored 10 years. 

Statistical analysis will be carried out by the investigators after the collection of retrospective data. For the prospective data-set analysis will be done once every 5 years. For all publications data protection for the personal data of the patients as well as of the participating investigators will be maintained.