Clinical trial NCT04176549: Assessment of Biomarkers in Ectopic Pregnancy
Official title: The Assessment of Biomarkers in Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ectopic Pregnancy
Keywords: Ectopic Pregnancy
Biomarker
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2019-11-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Pregnant women attending the Early Pregnancy Unit (EPU) within a hospital in the first trimester (up to 14 weeks gestation) with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18 and 50 years.
* Women attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.

Brief summary: To further develop a patient care pathway (incorporating a statistical model which uses the values of biomarkers) in routine clinical practice that will aid the diagnosis and management of women with an ectopic pregnancy.

Detailed description: Purpose and design-There is a need for the patient care pathway to evolve in order to aid and improve the diagnosis and management of women with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP). There is potential for this to be achieved by the incorporation of a statistical model that uses one or more novel markers identified by this study. These markers may replace or add to the effectiveness of markers used in the current statistical model.

Recruitment-200 patients. Inclusion: Patients attending the Early Pregnancy Unit (EPU) in the first trimester with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18-50 years. Exclusion: Patients diagnosed with cancer, presence of acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent.

Consent - Posters will advertise the study. Patients in EPU will be invited to the study by a member of the clinical care team. Written consent will be required for all aspects of the study other than for 3-dimensional scanning of PUL and EP patients, where verbal consent will be obtained. Patients will be given at least 24 hours to consider whether they wish to participate.

Confidentiality - The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on National Health Service (NHS) approved computers, accessible only by personnel involved in the study via password.

Conflict of interest - None involved in the study have a conflict of interest.

Dissemination of results - No patient identifiable information will be included in the research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings.

Eligibility criteria: Inclusion Criteria:

* Patients attending the Early Pregnancy Unit (EPU) in the first trimester (up to 14 weeks gestation) with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18 and 50 years.
* Patients attending the gynaecology unit for a surgical termination of pregnancy or for a salpingo-oophorectomy.

Exclusion Criteria:

* Patients diagnosed with cancer, presence of an acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent (language or learning impairment), presence of a viable intrauterine pregnancy and presence of miscarriage.
* Exclusion to fallopian tube samples - presence of any ectopic pregnancy that does not require operative salpingectomy.
* Exclusion to peritoneal washings - presence of any ectopic pregnancy that does not require access to the peritoneal cavity as part of management.
* Exclusion to trophoblast tissue sampling - presence of an ectopic pregnancy that does not require surgical removal.

Primary outcomes:
measure: Novel biomarkers for Ectopic Pregnancy prediction and diagnosis
timeFrame: 3 years
Secondary outcomes:
measure: microRNA as a biomarker
timeFrame: 3 years
measure: Microbiome as a biomarker
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Tom Bourne, MBBS, PhD, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bobdiwala S, Al-Memar M, Farren J, Bourne T. Factors to consider in pregnancy of unknown location. Womens Health (Lond). 2017 Aug;13(2):27-33. doi: 10.1177/1745505717709677. Epub 2017 Jun 29.
citation: Senapati S, Barnhart KT. Biomarkers for ectopic pregnancy and pregnancy of unknown location. Fertil Steril. 2013 Mar 15;99(4):1107-16. doi: 10.1016/j.fertnstert.2012.11.038. Epub 2013 Jan 3.
citation: Van Calster B, Bobdiwala S, Guha S, Van Hoorde K, Al-Memar M, Harvey R, Farren J, Kirk E, Condous G, Sur S, Stalder C, Timmerman D, Bourne T. Managing pregnancy of unknown location based on initial serum progesterone and serial serum hCG levels: development and validation of a two-step triage protocol. Ultrasound Obstet Gynecol. 2016 Nov;48(5):642-649. doi: 10.1002/uog.15864. Epub 2016 Oct 9.
citation: Bobdiwala S, Christodoulou E, Farren J, Mitchell-Jones N, Kyriacou C, Al-Memar M, Ayim F, Chohan B, Kirk E, Abughazza O, Guruwadahyarhalli B, Guha S, Vathanan V, Bottomley C, Gould D, Stalder C, Timmerman D, van Calster B, Bourne T. Triaging women with pregnancy of unknown location using two-step protocol including M6 model: clinical implementation study. Ultrasound Obstet Gynecol. 2020 Jan;55(1):105-114. doi: 10.1002/uog.20420.
citation: Cook J, Bennett PR, Kim SH, Teoh TG, Sykes L, Kindinger LM, Garrett A, Binkhamis R, MacIntyre DA, Terzidou V. First Trimester Circulating MicroRNA Biomarkers Predictive of Subsequent Preterm Delivery and Cervical Shortening. Sci Rep. 2019 Apr 10;9(1):5861. doi: 10.1038/s41598-019-42166-1.