Monitoring the Diagnosis and Management of Acute Leukaemia In Pregnancy Study.

Summary

Participation Requirements

Description

A registry-based cohort study to identify and collect data on all women receiving a diagnosis of AL or high-risk myelodysplastic syndrome (MDS), and all women with a history of AL or high-risk MDS who fall pregnant within the study period. This is an observational study, and patients will receive us...

A registry-based cohort study to identify and collect data on all women receiving a diagnosis of AL or high-risk myelodysplastic syndrome (MDS), and all women with a history of AL or high-risk MDS who fall pregnant within the study period. This is an observational study, and patients will receive usual care as determined by their Loco-regional multidisciplinary team. We aim to approach all consultant haematologists involved in the care of a woman diagnosed with AL during pregnancy, and request that they report all known cases, creating a national dataset. For prospective cases, women will be identified at diagnosis and tracked throughout their pregnancy to allow comparison of the respective outcomes for both mother and neonate. There will be additional follow-up points at 2 and 4 years, to accurately document the subsequent outcomes of the mother and obtain details of any further pregnancies they may have had. The follow-up periods were chosen as two and four years. Two years is where the most incidences of relapse occur, and four years is considered decisive with regards to remission. In addition, consultant haematologists across the UK will be asked to provide retrospective data on any cases occurring since August 2009 (both pre-and post-introduction of the 2015 BCSH guidelines), to gain an overview of current and past approaches to patient management, and to serve as comparators to assess the current and future impact of the BCSH guidelines. Consent will be sought from the patient whenever reasonably practicable for the use of the information in the database. In historic cases when to patient is no longer in contact with the hospital (e.g. no longer in clinical follow-up), to avoid causing any emotional distress the relevant approvals will be gained to process these cases without consent. All information will be retrieved from the patient's medical records and will require no further patient involvement beyond consenting for the use of their information. Data from the LIPS database will be hosted and managed by the Hull Health Trials Unit (HHTU) using their secure online data capture system RedCap Cloud (RCC) and BOX Governance file storage system. HHTU hold a NHS Digital Data Security and Protection Toolkit covering these information systems. RCC is a cloud based electronic data collection system provided by nPhase. Data is stored on dedicated RCC hardware in European Union data centres (including real-time backup) managed by Amazon Web Services to industry standards outlined in ISO 27001, PCI DSS, SOC 1 -3, FISMA, CIS, CSA, NIST and UK Cloud Security Principles. Data is encrypted at rest and in transit. RCC deliver compliance to HIPAA, CFR Part 11, and EMEA Annex 11. Data checks are built in to the database to compare inputted data with predefined ranges and values with data management according to the data management plan with data querying of any missing or anomalous data. A statistical analysis plan will be prepared before the analysis of the initial dataset.

Tracking Information