MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact (MATCHING)

March 16, 2026 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

The aim of this study is to evaluate the prevalence of female genital schistosomiasis (FGS) in the migrant population with gynecological problems who access our center's dedicated outpatient clinic. Furthermore, we will address the relevance of FGS in women with clinical manifestations of the upper genital tract and evaluate the role of cervical-vaginal swabs in predicting upper genital tract involvement in schistosomiasis infection.

The study is classified as experimental despite its descriptive objective of the prevalence of the infection of interest, as the vaginal swab and the PCR test performed on the swab and, if necessary, on the histological sample (collected during a possible interventional procedure performed for the patient's clinical needs) are not part of the standard clinical management of these cases but will be performed for the purposes of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • IRCCS Sacro Cuore Don Calabria hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • childbearing age (15-49 years);
  • origin from Schistosoma -endemic country;
  • presence of at least one of the following symptoms compatible with FGS: abnormal vaginal discharge, vaginal spotting/bleeding, genital itching or burning sensation, pelvic pain/dyspareunia, genital ulcers, macrohematuria, subfertility/infertility, miscarriage and/or extrauterine pregnancy, unexplained anemia, menstrual irregularities, previous birth of a premature/low birth weight fetus or growth retarded baby;
  • Informed consent to study participation and to personal data's treatment.

Exclusion Criteria:

  • Deny of informed consent to study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants

Women diagnosed with schistosomiasis and complaining gynecological symptoms will be referred to the gynecologist. Upon gynecological evaluation, informed consent to enrolment in the study will be sought. If necessary, cultural mediation will be requested for the collection of consent.

One cervical-vaginal swab will be collected by the gynecologist, being specifically performed for the study purpose. For patients requiring hysteroscopy, hysterectomy or other procedures entailing collection/removal of endometrial tissue, part of retrieved biological material will be collected for molecular analysis. During the hysteroscopic examination/hysterectomy/revision of uterine cavity, bioptic samples will be collected as per standard procedure, part of which will be used for routine histological examination at the pathological anatomy department, and the leftover will be sent to the parasitology laboratory for molecular detection of Schistosoma spp DNA using in-house real-time PCR.
Procedure: Cervical-vaginal swab
One cervical-vaginal swab will be collected by the gynecologist and will be sent to the parasitology laboratory of DITM for molecular detection of Schistosoma spp DNA using in-house real-time PCR.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Female Genital Schistosomiasis (FGS)
Time Frame: At baseline
Proportion of FGS cases, defined as women with the given symptoms/signs and positive real-time PCR on cervical-vaginal swab and/or biopsy over the total number of women tested.
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Signs/symptoms
Time Frame: At baseline

Frequency of specific signs/symptoms (Y/N) in patients diagnosed with FGS:

  • abnormal vaginal discharge
  • vaginal spotting/bleeding
  • genital itching or burning sensation
  • pelvic pain/dyspareunia
  • genital ulcers
  • macrohematuria
  • subfertility/infertility
  • miscarriage and/or extrauterine pregnancy
  • unexplained anemia
  • menstrual irregularities
  • previous birth of a premature/low birth weight fetus or growth retarded baby -histopathological features (presence of Schistosoma eggs in female genital tissues),
  • UGT involvement
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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