Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia

Hypertension Clinical Trial

— Lumella  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06085001
• Other study ID #: 329116
• Status: Not yet recruiting
• Start date: November 10, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• Source: Croydon University Hospital
• Contact: Michael Chang
• Phone: +442084013610
• Email: michael.chang[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• If they can speak English

• Can give informed consent

• Has symptoms of Preeclampsia

Exclusion Criteria:

• Can't speak English

• Does not want to participate

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Related

Intervention

Diagnostic Test:
• Lumella finger prick blood test
Finger prick blood test

Locations

Country	Name	City	State
United Kingdom	Croydon University Hospital	Croydon	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Croydon University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	can we use a bedside test -glycosylated fibronectin for the early diagnosis of pre-eclampsia	Does the test work?	6 months
Secondary	Is glycosylated fibronectin better than placental growth factor or traditional blood tests	Is the test better than PLGF/traditional blood tests	6 months

External Links

•   AM J Obstet Gynecol 2015;212:82.e1-9 Maternal Serum glycosylated fibronectin as a point-of-care biomarker for assessment of preeclampsia
•   Huhn et al. BMC Pregnancy and Childbirth (2020) 20:128 https://doi.org/10.1186/s12884-020-2809-2