Acute LeukemiaLIPSNCT04182074
Monitoring the Diagnosis and Management of Acute Leukaemia In Pregnancy Study.
An observational study of Acute Leukemia, run by University of Hull at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Acute Leukemia
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2019to 30 Sep 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Secondary care in the UK
Who may be able to join
- 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.
Who cannot join
- Pregnant women not meeting the inclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Registry-based Cohort Study to Monitor the Diagnosis and Management of Acute Leukaemia in Pregnancy.
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.
Read the detailed 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 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.
- Conditions
- Acute Leukemia
- Keywords
- Pregnancy, Treatment, Diagnosis, Delivery
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 month after delivery.
Secondary outcomes (8)
Number and types of treatments used during the pregnancy.
Current treatment practices for women diagnosed with AL or high-risk MDS during pregnancy.
Measured: Up to the 9 months of the pregnancy.
Number and types of monitoring procedures used during the pregnancy.
Current monitoring practices for women diagnosed with AL or high-risk MDS during pregnancy.
Measured: Up to the 9 months of the pregnancy.
Number and types of treatments who subsequently become pregnant.
Current treatment practices for women who became pregnant after previously receiving therapy for AL or high-risk MDS.
Measured: 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.
Current monitoring practices for women who became pregnant after previously receiving therapy for AL or high-risk MDS.
Measured: Up to the 9 months of the pregnancy.
Number of deaths during the follow-up period.
Long term mortality of the woman.
Measured: Mother - Up to 4 years after delivery.
Number of further pregnancies and outcome of the pregnancy.
Long term treatment effects on the fertility.
Measured: Mother - Up to 4 years after delivery.
Number of women with treatment-related adverse events as assessed by CTCAE v4.0.
Long term side effect of treatment to the woman.
Measured: Mother - Up to 4 years after delivery.
Number of congenital abnormalities reported in the infant up to 28 days after delivery
Side effects of treatment to the infant.
Measured: Child - Up to 28 days after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start22 Nov 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahra Ali, MBChB, MRCP, FRCPath, Principal investigator, Guy's and St Thomas' NHS Foundation TrustDavid Allsup, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182074
- Sponsor's protocol ID
- UoH 2019/01
- Acronym
- LIPS
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26081614Northgraves 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.
PubMed 35130292
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry-based Cohort Study to Monitor the Diagnosis and Management of Acute Leukaemia in Pregnancy.
- ClinicalTrials.gov ID
- NCT04182074
- Acronym / sponsor ID
- LIPS / UoH 2019/01
- Conditions
- Acute Leukemia
- Keywords
- Pregnancy, Treatment, Diagnosis, Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Secondary care in the UK
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women not meeting the inclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of deaths and complications during pregnancy and up to one month after delivery.
Time frame: Up to 1 month after delivery.
Morbidity and mortality outcomes of women treated for AL or high-risk MDS during pregnancy.
Number of neonatal deaths and complications during pregnancy and up to one month after delivery.
Time frame: Up to 1 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.
Number of deaths and complications during pregnancy.
Time frame: Up to 1 month after delivery.
Morbidity and mortality outcomes during pregnancy of women previously treated for AL or high-risk MDS.
Number of neonatal deaths and complications during pregnancy and up to one month after.
Time frame: Up to 1 month after delivery.
Short term morbidity and mortality outcomes of neonates born by women who were previously treated for AL or high-risk MDS.
8 secondary outcomes
Number and types of treatments used during the pregnancy.
Time frame: Up to the 9 months of the pregnancy.
Number and types of monitoring procedures used during the pregnancy.
Time frame: Up to the 9 months of the pregnancy.
Number and types of treatments who subsequently become pregnant.
Time frame: 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.
Time frame: Up to the 9 months of the pregnancy.
Number of deaths during the follow-up period.
Time frame: Mother - Up to 4 years after delivery.
Number of further pregnancies and outcome of the pregnancy.
Time frame: Mother - Up to 4 years after delivery.
Number of women with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Mother - Up to 4 years after delivery.
Number of congenital abnormalities reported in the infant up to 28 days after delivery
Time frame: Child - Up to 28 days after birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 26081614Ali 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.
- Background: PubMed 35130292Northgraves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahra Ali, MBChB, MRCP, FRCPath principal investigator
Guy's and St Thomas' NHS Foundation Trust
David Allsup principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths and complications during pregnancy and up to one month after delivery. (time frame: Up to 1 month after delivery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.