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

NCT04182074 | Completed

• 1 other identifier: UoH 2019/01
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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. Patients will receive the treatment recommended by their doctor, the study will not alter the treatment pathway of participants. This study will establish a new research database of Leukaemia in Pregnancy, initially collecting data from cases since August 2009, and any new cases that are diagnosed during the current funding period. The initial planned analyses from this dataset 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 National Health Service (NHS) Trusts and patients across the United Kingdom (UK) through more informed clinical decision making with regards to the care they receive. It will also provide an important data resource which researchers can apply to use in further analyses, with plans to continue data collection if further funding is obtained.

Conditions

Acute Leukemia

Keywords

Pregnancy; Treatment; Diagnosis; Delivery

Outcome Measures

Primary Outcomes (4)

• Number of deaths and complications during pregnancy and up to one month after delivery.

  Morbidity and mortality outcomes of women treated for AL or high-risk MDS during pregnancy.

  Up to 1 month after delivery.

• Number of neonatal deaths and complications during pregnancy and up to one month after delivery.

  Short term morbidity and mortality outcomes for neonates born by women who were treated for AL or high-risk MDS during pregnancy.

  Up to 1 month after delivery.

• Number of deaths and complications during pregnancy.

  Morbidity and mortality outcomes during pregnancy of women previously treated for AL or high-risk MDS.

  Up to 1 month after delivery.

• Number of neonatal deaths and complications during pregnancy and up to one month after.

  Short term morbidity and mortality outcomes of neonates born by women who were previously treated for AL or high-risk MDS.

  Up to 1 month after delivery.

Secondary Outcomes (8)

• Number and types of treatments used during the pregnancy.

  Up to the 9 months of the pregnancy.

• Number and types of monitoring procedures used during the pregnancy.

  Up to the 9 months of the pregnancy.

• Number and types of treatments who subsequently become pregnant.

  Up to the 9 months of the pregnancy.

• Number and types of monitoring procedures used during the pregnancy in women who previously received therapy for AL or high-risk MDS.

  Up to the 9 months of the pregnancy.

• Number of deaths during the follow-up period.

  Mother - Up to 4 years after delivery.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care in the UK

You may qualify if:

• Women who have a diagnosis of acute leukaemia (AL) or high-risk myelodysplasia (MDS) in pregnancy, or who have later conceived after receiving previous treatment for either AL or high-risk MDS.

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull University Teaching Hospital NHS Trust

Hull, United Kingdom

Location

Related Publications (2)

• Ali S, Jones GL, Culligan DJ, Marsden PJ, Russell N, Embleton ND, Craddock C; British Committee for Standards in Haematology. Guidelines for the diagnosis and management of acute myeloid leukaemia in pregnancy. Br J Haematol. 2015 Aug;170(4):487-95. doi: 10.1111/bjh.13554. Epub 2015 Jun 17.

  PMID: 26081614 BACKGROUND

• Northgraves M, Allsup D, Cohen J, Huang C, Turgoose J, Ali S. A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol. PLoS One. 2022 Feb 7;17(2):e0263195. doi: 10.1371/journal.pone.0263195. eCollection 2022.

  PMID: 35130292 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sahra Ali, MBChB, MRCP, FRCPath

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• David Allsup

  Hull York Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 2, 2019
• Study Start: November 22, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

GB (1)