Acute Leukemia in Pregnancy Registry Study (LIPS)
Research type
Research Database
IRAS ID
238879
Contact name
David Allsup
Contact email
Research summary
Acute Leukemia in Pregnancy Registry Study
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0356
Date of REC Opinion
2 Aug 2019
REC opinion
Further Information Favourable Opinion
Data collection arrangements
A secure online database will be provided by the Hull Health Trials Unit (HHTU). Once a case is identified, each patient will be designated a unique study identification number, generated automatically by the HHTU electronic database system. Different case report forms will be activated accordingly as data is entered onto the database.
Data will be collected directly into the study database by the consultant haematologist through reference to medical records only, there will be no direct contact with patients. All data will be reported anonymously using the patient ID. Email reminders for case report completion will be sent every three months.
Data collection will include information on the following; diagnosis and treatment, pregnancy, delivery and outcomes, follow-up. The only personal information obtained is year of birth for the mother, date of birth of child, date of death of mother/child if applicable, gender of child.
Research programme
Acute leukaemia (AL) is an aggressive but potentially curable cancer that can affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother's survival through delaying treatment, against the potential harm to the foetus through exposure to cancer drugs. Reports suggest that, providing the first trimester is avoided, successful treatment of AL during pregnancy is possible, and considered safe. However, there is currently no standard approach to treatment of these women. This observational study aims to monitor and record the current treatment and outcomes of patients diagnosed with acute leukaemia during or prior to pregnancy in the past ten years, and any new cases that are diagnosed during the period of the study. Patients will receive the treatment recommended by their doctor, the study will not alter the treatment pathway of participants. The successful completion of the study will enable more robust, evidence-based recommendations to be made on how to monitor and manage these patients, and will add value to and improve the existing British Committee for Standards in Haematology (BCSH) guidelines, which were largely derived from expert opinion. This should enable healthcare professionals to have greater confidence in managing these patients, leading to a more standardised approach to providing high quality care. The study will benefit NHS Trusts and patients across the UK through more informed clinical decision making with regards to the care they receive.
Research database title
Acute Leukemia in Pregnancy Registry Study
Establishment organisation
University of Hull
Establishment organisation address
Cottingham Road
Hull
HU6 7RX