Female Genital SchistosomiasisMATCHINGNCT07484256
MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact
A study testing Cervical-vaginal swab in people with Female Genital Schistosomiasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Female Genital Schistosomiasis
- What is being tested?
- Cervical-vaginal swab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Deny of informed consent to study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Tamara Ursini, +390456013226, tamara.ursini@sacrocuore.it
About this study
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.
- Conditions
- Female Genital Schistosomiasis
- Being tested
- Cervical-vaginal swab
- Keywords
- female, genital, schistosomiasis
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical-vaginal swabProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | 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. Receives: Procedure: Cervical-vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Genital Schistosomiasis (FGS)
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.
Measured: At baseline
Secondary outcomes (1)
Signs/symptoms
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital SchistosomiasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484256
- Sponsor's protocol ID
- 2024-29
- Acronym
- MATCHING
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact
- ClinicalTrials.gov ID
- NCT07484256
- Acronym / sponsor ID
- MATCHING / 2024-29
- Conditions
- Female Genital Schistosomiasis
- Keywords
- female, genital, schistosomiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Mar 2026 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Procedure: Cervical-vaginal swabWomen 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Deny of informed consent to study participation.
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 |
|---|---|---|
| Cervical-vaginal swabOne 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. | Procedure or surgery | Participants |
Primary outcome
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.
1 secondary outcome
Signs/symptoms
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical-vaginal swab in people with Female Genital Schistosomiasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456013111, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Genital Schistosomiasis (FGS) (time frame: At baseline). 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 20 Mar 2026.