PreeclampsiaLumellaNCT06085001
Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia
An observational study of Preeclampsia and Pregnancy Related, run by Croydon University Hospital at 1 site in United Kingdom.
Trial summary
women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia, Pregnancy Related, Hypertension
- What is being tested?
- Lumella finger prick blood test
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2023to 30 Aug 2024
- 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: Pregnant Women
Who may be able to join
- If they can speak English
- Can give informed consent
- Has symptoms of Preeclampsia
Who cannot join
- Can't speak English
- Does not want to participate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Croydon University Hospital
Croydon, Surrey, CR7 7YE
michael chang, +442084013610, michael.chang@nhs.net
About this study
Official title: Lumella is a Point of Care Blood Test Used Together With Other Blood Tests to Assess the Risk of Preeclampsia in Pregnancy in 10 Minutes. Measurements of the Biomarker.
women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE.
Read the detailed description
Pre-eclampsia is a potentially serious condition that affects pregnant women. It is usually diagnosed during routine antenatal appointments. This is based on blood pressure measurements and results of urine protein tests that are recommended at each routine antenatal visit to screen for the condition. The Triage PlGF test and the Elecsys immunoassay sFlt-1/PlGF ratio is also recommended to help rule out the condition in women presenting with suspected pre-eclampsia between 20 weeks and 34 weeks of pregnancy plus 6 days. If diagnosed with pre-eclampsia, women are usually referred to a specialist in hospital for further tests and more frequent monitoring. Depending on the severity of the condition, some women may be monitored as outpatients while others may need admission to hospital for closer monitoring or to have the condition managed in a critical care setting.
The Lumella test is based on the novel biomarker GlyFn. The company states that compared with other currently used biomarkers (such as soluble fms-like tyrosine kinase-1 [sfIT-1] and placental growth factor [PlGF] or PlGF alone), GlyFn is etiological to pre-eclampsia and maintains a linear progression throughout pregnancy. The company also claims that the test offers improved sensitivity and specificity over standard care tests. This would lead to a reduction in false positives and false negatives. The Lumella test requires a finger prick blood sample (5 microlitres). Other pre-eclampsia tests currently used in the NHS need a phlebotomy blood sample, which can be difficult to collect in some people. The test can also be transported and stored at room temperature. Other tests for pre-eclampsia need to be refrigerated and brought to room temperature before the test can be done. The Lumella test may improve patient experience and allow a more rapid turnaround time for results. The company states that Lumella is currently the only test that can be done within 10 minutes at room temperature.
- Conditions
- Preeclampsia, Pregnancy Related, Hypertension
- Being tested
- Lumella finger prick blood test
- Keywords
- Preeclampsia, PET
- Medical subject headings
- Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumella finger prick blood testDiagnostic test
Finger prick blood test
| Study group | Role | What they receive |
|---|---|---|
| Women with preeclampsia | women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE. Receives: Diagnostic Test: Lumella finger prick blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
can we use a bedside test -glycosylated fibronectin for the early diagnosis of pre-eclampsia
Does the test work?
Measured: 6 months
Secondary outcomes (1)
Is glycosylated fibronectin better than placental growth factor or traditional blood tests
Is the test better than PLGF/traditional blood tests
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start10 Nov 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Croydon University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bini Ajay, Croydon University Hospital
- Investigators
- Bini Ajay, Principal investigator, Croydon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085001
- Sponsor's protocol ID
- 329116
- Acronym
- Lumella
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing identifiable data
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumella is a Point of Care Blood Test Used Together With Other Blood Tests to Assess the Risk of Preeclampsia in Pregnancy in 10 Minutes. Measurements of the Biomarker.
- ClinicalTrials.gov ID
- NCT06085001
- Acronym / sponsor ID
- Lumella / 329116
- Conditions
- Preeclampsia, Pregnancy Related, Hypertension
- Keywords
- Preeclampsia, PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Croydon University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 16 Oct 2023 (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.
women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE.
Detailed description
Pre-eclampsia is a potentially serious condition that affects pregnant women. It is usually diagnosed during routine antenatal appointments. This is based on blood pressure measurements and results of urine protein tests that are recommended at each routine antenatal visit to screen for the condition. The Triage PlGF test and the Elecsys immunoassay sFlt-1/PlGF ratio is also recommended to help rule out the condition in women presenting with suspected pre-eclampsia between 20 weeks and 34 weeks of pregnancy plus 6 days. If diagnosed with pre-eclampsia, women are usually referred to a specialist in hospital for further tests and more frequent monitoring. Depending on the severity of the condition, some women may be monitored as outpatients while others may need admission to hospital for closer monitoring or to have the condition managed in a critical care setting.
The Lumella test is based on the novel biomarker GlyFn. The company states that compared with other currently used biomarkers (such as soluble fms-like tyrosine kinase-1 [sfIT-1] and placental growth factor [PlGF] or PlGF alone), GlyFn is etiological to pre-eclampsia and maintains a linear progression throughout pregnancy. The company also claims that the test offers improved sensitivity and specificity over standard care tests. This would lead to a reduction in false positives and false negatives. The Lumella test requires a finger prick blood sample (5 microlitres). Other pre-eclampsia tests currently used in the NHS need a phlebotomy blood sample, which can be difficult to collect in some people. The test can also be transported and stored at room temperature. Other tests for pre-eclampsia need to be refrigerated and brought to room temperature before the test can be done. The Lumella test may improve patient experience and allow a more rapid turnaround time for results. The company states that Lumella is currently the only test that can be done within 10 minutes at room temperature.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with preeclampsia | – | Diagnostic Test: Lumella finger prick blood testwomen with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant Women
Key inclusion criteria (3 listed)
- If they can speak English
- Can give informed consent
- Has symptoms of Preeclampsia
Key exclusion criteria (2 listed)
- Can't speak English
- Does not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumella finger prick blood testFinger prick blood test | Diagnostic test | Women with preeclampsia |
Primary outcome
can we use a bedside test -glycosylated fibronectin for the early diagnosis of pre-eclampsia
Time frame: 6 months
Does the test work?
1 secondary outcome
Is glycosylated fibronectin better than placental growth factor or traditional blood tests
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Huhn et al. BMC Pregnancy and Childbirth (2020) 20:128 https://doi.org/10.1186/s12884-020-2809-2Link provided by the sponsor.
- AM J Obstet Gynecol 2015;212:82.e1-9 Maternal Serum glycosylated fibronectin as a point-of-care biomarker for assessment of preeclampsiaLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not sharing identifiable data
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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.
Bini Ajay principal investigator
Croydon University Hospital
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 Preeclampsia and Pregnancy Related, run by Croydon University Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Chang (+442084013610, michael.chang@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
can we use a bedside test -glycosylated fibronectin for the early diagnosis of pre-eclampsia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2023.