Assessment of Biomarkers in Ectopic Pregnancy

Brief Title

Assessment of Biomarkers in Ectopic Pregnancy

Official Title

The Assessment of Biomarkers in Ectopic Pregnancy

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.
    

Study Type

Observational

Primary Outcome

Novel biomarkers for Ectopic Pregnancy prediction and diagnosis

Secondary Outcome

 microRNA as a biomarker

Condition

Ectopic Pregnancy

Intervention

Management of Ectopic Pregnancy

Study Arms / Comparison Groups

 Ectopic Pregnancy

Description:  Patients diagnosed with ectopic pregnancy Samples collected: Plasma, Serum, Urine, Oral swab, Vaginal Swab If surgery required for tubal ectopic: Fallopian tube, peritoneal washing, trophoblast

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

200

Start Date

November 18, 2019

Completion Date

December 31, 2025

Primary Completion Date

December 31, 2025

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.
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Tom Bourne, MBBS, PhD, MRCOG, 0044 203 313 5131, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT04176549

Organization ID

18HH4883

Responsible Party

Sponsor

Study Sponsor

Imperial College London

Collaborators

 Imperial College Healthcare NHS Trust

Study Sponsor

Tom Bourne, MBBS, PhD, MRCOG, Principal Investigator, Imperial College London

Verification Date

July 2022