EchinococcosisHIS-QPCR-ECHNCT05824442
Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis
A study testing Blood sample for multiplex QPCR technique in people with Echinococcosis and Diagnosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Echinococcosis is a severe parasitosis caused by the development of the tapeworm larva Echinococcus multilocularis, responsible for alveolar echinococcosis (AE) or Echinococcus granulosus, responsible for cystic echinococcosis (CE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echinococcosis, Diagnosis
- What is being tested?
- Blood sample for multiplex QPCR technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2023to Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged >18 years with a diagnosis of echinococcosis (Alveolar Echinococcosis or Cystic Echinococcosis) established according to the reference criteria
- Signature of the informed consent form indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions about this study
- Affiliation to a French social security scheme or beneficiary of such a scheme.
Who cannot join
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- Subject being in the period of exclusion from another study or provided by the "national volunteer file".
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Echinococcosis is a severe parasitosis caused by the development of the tapeworm larva Echinococcus multilocularis, responsible for alveolar echinococcosis (AE) or Echinococcus granulosus, responsible for cystic echinococcosis (CE). The treatment is based on surgery (only possible in 30 to 40% of cases) and/or on a benzimidazole antiparasitic treatment, especially albendazole. Albendazole is only parasitostatic, it slows down the development of the parasite but does not kill it. It is often prescribed for life. Monitoring the effectiveness of the treatment is therefore necessary, requiring radiological and serological monitoring once or twice a year. Being a chronic disease whose treatment is not always curative, patients quality of life is impacted, with a high level of anxiety described in some patients.
The diagnosis, evoked on radiological arguments, is then confirmed by serological techniques, whose sensitivity for EA diagnosis is good (95%) in the absence of immunosuppression (now observed in 25% of EA patients). Sensitivity is lower for CE diagnosis (70% or even less than 50% in certain clinical forms).
Read more
Quantitative real-time PCR (QPCR) techniques on blood samples are now used in many infectious pathologies to quantify the circulating DNA load, and improve diagnosis and therapeutic monitoring. The presence of circulating parasitic DNA has been reported in both types of echinococcosis.
A new Echinococcus spp.multiplex QPCR technique (QPCR-Echino) allowing the detection of DNA from E. multilocularis and different species of the E. granulosus complex of European occurrence, in different types of biological samples, has recently been developed in the French National Reference Center for Echinococcosis laboratory.
The investigators wish to evaluate QPCR-Echino for the detection of DNA in tissues, as well as in blood, for the diagnosis of Echinococcosis. This technique could improve the sensitivity of biological diagnosis, especially in immunocompromised patients, who often experience significant diagnostic delays, and could also provide information on the virulence and viability of the strains involved.
- Conditions
- Echinococcosis, Diagnosis
- Being tested
- Blood sample for multiplex QPCR technique
- Keywords
- High sensitive qPCR
- Medical subject headings
- Echinococcosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for multiplex QPCR techniqueBiological
Blood sampling specifically for qPCR Echino at inclusion and one year after
| Study group | Role | What they receive |
|---|---|---|
| Biological sample | Experimental | Blood sample Receives: Biological: Blood sample for multiplex QPCR technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance indicators of a new diagnosis technique based on multiplex quantitative PCR
sensitivity of DNA detection by QPCR-Echino in tissues (operating specimens, biopsies, puncture fluids) and in blood (plasma)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start24 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchinococcosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine VERHOEVEN-WEIL, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824442
- Sponsor's protocol ID
- 2022/737
- Acronym
- HIS-QPCR-ECH
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2023
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis
- ClinicalTrials.gov ID
- NCT05824442
- Acronym / sponsor ID
- HIS-QPCR-ECH / 2022/737
- Conditions
- Echinococcosis, Diagnosis
- Keywords
- High sensitive qPCR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Apr 2023 (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.
Echinococcosis is a severe parasitosis caused by the development of the tapeworm larva Echinococcus multilocularis, responsible for alveolar echinococcosis (AE) or Echinococcus granulosus, responsible for cystic echinococcosis (CE). The treatment is based on surgery (only possible in 30 to 40% of cases) and/or on a benzimidazole antiparasitic treatment, especially albendazole. Albendazole is only parasitostatic, it slows down the development of the parasite but does not kill it. It is often prescribed for life. Monitoring the effectiveness of the treatment is therefore necessary, requiring radiological and serological monitoring once or twice a year. Being a chronic disease whose treatment is not always curative, patients quality of life is impacted, with a high level of anxiety described in some patients.
The diagnosis, evoked on radiological arguments, is then confirmed by serological techniques, whose sensitivity for EA diagnosis is good (95%) in the absence of immunosuppression (now observed in 25% of EA patients). Sensitivity is lower for CE diagnosis (70% or even less than 50% in certain clinical forms).
Quantitative real-time PCR (QPCR) techniques on blood samples are now used in many infectious pathologies to quantify the circulating DNA load, and improve diagnosis and therapeutic monitoring. The presence of circulating parasitic DNA has been reported in both types of echinococcosis.
A new Echinococcus spp.multiplex QPCR technique (QPCR-Echino) allowing the detection of DNA from E. multilocularis and different species of the E. granulosus complex of European occurrence, in different types of biological samples, has recently been developed in the French National Reference Center for Echinococcosis laboratory.
The investigators wish to evaluate QPCR-Echino for the detection of DNA in tissues, as well as in blood, for the diagnosis of Echinococcosis. This technique could improve the sensitivity of biological diagnosis, especially in immunocompromised patients, who often experience significant diagnostic delays, and could also provide information on the virulence and viability of the strains involved.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological sample | Experimental | Biological: Blood sample for multiplex QPCR techniqueBlood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged >18 years with a diagnosis of echinococcosis (Alveolar Echinococcosis or Cystic Echinococcosis) established according to the reference criteria
- Signature of the informed consent form indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions about this study
- Affiliation to a French social security scheme or beneficiary of such a scheme.
Key exclusion criteria (5 listed)
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- Subject being in the period of exclusion from another study or provided by the "national volunteer file".
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 |
|---|---|---|
| Blood sample for multiplex QPCR techniqueBlood sampling specifically for qPCR Echino at inclusion and one year after | Biological | Biological sample |
Primary outcome
Performance indicators of a new diagnosis technique based on multiplex quantitative PCR
Time frame: 1 year
sensitivity of DNA detection by QPCR-Echino in tissues (operating specimens, biopsies, puncture fluids) and in blood (plasma)
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 1 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Echinococcosis
RecruitingObservational study
Collection of Biological Samples From Patients With Echinococcosis and Implementation of a Home-made PCR Method
Echinococcosis
Not yet recruitingEarly Phase 1
5G Remote Robotic Surgery for Hepatic Echinococcosis in High-Altitude Region
Hepatic Echinococcosis
RecruitingObservational study
IM Bands in Inactive Hepatic CE
Cystic Echinococcosis
Recruiting
Biliary Fistulas in Surgery of Liver Echinococcosis
Echinococcosis, Hepatic, Biliary Fistula
RecruitingObservational study
Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver With Echinococcosis
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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.
Delphine VERHOEVEN-WEIL, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample for multiplex QPCR technique in people with Echinococcosis and Diagnosis, run by Centre Hospitalier Universitaire de Besancon 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 5 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 1 Feb 2024. 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?
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 Laurence MILLON, PharmD, PhD (0370632353, lmillon@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance indicators of a new diagnosis technique based on multiplex quantitative PCR (time frame: 1 year). 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 1 Feb 2024.