StrongyloidiasisSEROANGUILLULONCT07296198
Strongyloidiasis at CHRU Nancy: Evaluation of the Performance of Serological Tests and Disease-associated Characteristics
An observational study of Strongyloidiasis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Strongyloidiasis is a disease caused by a parasite belonging to the helminth phylum: Strongyloides stercoralis. This nematode is mainly found in warm and humid regions, which favor its survival and transmission to humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strongyloidiasis
- What is being tested?
- Strongyloides serology
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with strongyloidiasis serology performed between January 2024 and June 2025
Who may be able to join
- Adult patients with strongyloidiasis serology performed between January 2024 and June 2025
- Whose serum tube residues are available in the biobank
- Who have not objected to the reuse of their data for research purposes
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Strongyloidiasis is a disease caused by a parasite belonging to the helminth phylum: Strongyloides stercoralis. This nematode is mainly found in warm and humid regions, which favor its survival and transmission to humans. The disease presents several clinical forms: symptomatic forms, which are characteristic and make diagnosis easier, but also asymptomatic forms, where the parasite remains dormant in the human body thanks to the immune system. The latter form is particularly dangerous in cases of immunosuppression (cancers, corticosteroid treatment) or during organ donation. Therefore, knowing the serological status of a patient who has lived in an endemic area is essential to prevent severe strongyloidiasis.
To mitigate this risk, a new recommendation (2023) regarding the serological screening of organ donors has been issued, specifically concerning strongyloidiasis serology. To meet this requirement, the CHRU Nancy laboratory implemented an ELISA serological technique for detecting immunoglobulins directed against the parasite (Strongyloides stercoralis). A call for tenders was launched in summer 2025, with three responses from different suppliers (Launch, Euroimmun, Bordier).
Read more
Over the past 15 months, 600 serological tests have been performed, including 60 positive and 20 borderline results. The question is whether these results represent true strongyloidiasis cases and to assess the diagnostic performance of the technique used, particularly its specificity and sensitivity.
Primary objective:
Evaluate the performance of the three ELISA serological techniques for diagnosing strongyloidiasis.
Secondary objectives:
Identify and assess the socio-demographic, clinical, biological, and epidemiological characteristics of patients with strongyloidiasis.
Evaluate compliance with recommendations by healthcare professionals when faced with a positive strongyloidiasis serology (recommendations: add microfilaria serology and initiate ivermectin treatment).
Identify the context in which strongyloidiasis serology is prescribed (diagnosis of digestive parasitosis, compliance with PMO/organ recipient recommendations, pre-immunosuppression workup, etc.).
- Conditions
- Strongyloidiasis
- Being tested
- Strongyloides serology
- Medical subject headings
- Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strongyloides serologyDiagnostic test
serological test for Strongyloides antibody
What is being measured
The primary outcome is the main question the study is designed to answer.
serological result
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start5 Sep 2025
- Primary completion1 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrongyloidiasisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne DEBOURGOGNE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296198
- Sponsor's protocol ID
- 2025PI080
- Acronym
- SEROANGUILLULO
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strongyloidiasis at CHRU Nancy: Evaluation of the Performance of Serological Tests and Disease-associated Characteristics
- ClinicalTrials.gov ID
- NCT07296198
- Acronym / sponsor ID
- SEROANGUILLULO / 2025PI080
- Conditions
- Strongyloidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 22 Dec 2025 (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.
Strongyloidiasis is a disease caused by a parasite belonging to the helminth phylum: Strongyloides stercoralis. This nematode is mainly found in warm and humid regions, which favor its survival and transmission to humans. The disease presents several clinical forms: symptomatic forms, which are characteristic and make diagnosis easier, but also asymptomatic forms, where the parasite remains dormant in the human body thanks to the immune system. The latter form is particularly dangerous in cases of immunosuppression (cancers, corticosteroid treatment) or during organ donation. Therefore, knowing the serological status of a patient who has lived in an endemic area is essential to prevent severe strongyloidiasis.
To mitigate this risk, a new recommendation (2023) regarding the serological screening of organ donors has been issued, specifically concerning strongyloidiasis serology. To meet this requirement, the CHRU Nancy laboratory implemented an ELISA serological technique for detecting immunoglobulins directed against the parasite (Strongyloides stercoralis). A call for tenders was launched in summer 2025, with three responses from different suppliers (Launch, Euroimmun, Bordier).
Over the past 15 months, 600 serological tests have been performed, including 60 positive and 20 borderline results. The question is whether these results represent true strongyloidiasis cases and to assess the diagnostic performance of the technique used, particularly its specificity and sensitivity.
Primary objective:
Evaluate the performance of the three ELISA serological techniques for diagnosing strongyloidiasis.
Secondary objectives:
Identify and assess the socio-demographic, clinical, biological, and epidemiological characteristics of patients with strongyloidiasis.
Evaluate compliance with recommendations by healthcare professionals when faced with a positive strongyloidiasis serology (recommendations: add microfilaria serology and initiate ivermectin treatment).
Identify the context in which strongyloidiasis serology is prescribed (diagnosis of digestive parasitosis, compliance with PMO/organ recipient recommendations, pre-immunosuppression workup, etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with strongyloidiasis serology performed between January 2024 and June 2025
Key inclusion criteria (3 listed)
- Adult patients with strongyloidiasis serology performed between January 2024 and June 2025
- Whose serum tube residues are available in the biobank
- Who have not objected to the reuse of their data for research purposes
Key exclusion criteria (1 listed)
- < 18 years old
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 |
|---|---|---|
| Strongyloides serologyserological test for Strongyloides antibody | Diagnostic test | – |
Primary outcome
serological result
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Related trials for Strongyloidiasis
RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strongyloidiasis, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 22 Dec 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serological result (time frame: 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 22 Dec 2025.