Whipple DiseaseWHIPNCT06776484
Biological Evolution of Whipple's Disease (WHIP)
An observational study of Whipple Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
Whipple's disease (WD), a rare systemic infection by Tropheryma whipplei, lacks research on biological abnormalities pre- and post-treatment. This study explores these abnormalities for their diagnostic and monitoring value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whipple Disease
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 31 Dec 2024
- 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: Retrospective study of patients hospitalised in Brest who tested positive for Whipple's disease between 2010 and 2024
Who may be able to join
- Patients with at least one positive PCR test for Whipple's disease and a retained diagnosis at Brest University Hospital between 2010 and 2024
- Major patient
Who cannot join
- Minors
- No screening test for Whipple's disease
- Opposition to participation
- Protected patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Evolution of Whipple's Disease
Whipple's disease (WD), a rare systemic infection by Tropheryma whipplei, lacks research on biological abnormalities pre- and post-treatment. This study explores these abnormalities for their diagnostic and monitoring value.
Read the detailed description
Whipple's disease (WD) is a rare systemic infection caused by *Tropheryma whipplei*. Despite advancements in diagnosis through PCR and biopsy, there is limited research comparing biological abnormalities before and after treatment. This study aimed to characterize these abnormalities and evaluate their potential for aiding in diagnosis and monitoring.
- Conditions
- Whipple Disease
- Medical subject headings
- Whipple Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological changes
Biological changes (inflammation, liver function tests, haematology, lymphocyte subpopulations) in patients diagnosed with classic, localised or reactive Whipple's disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Sep 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whipple DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776484
- Sponsor's protocol ID
- 29BRC24.0315 - WHIP
- Acronym
- WHIP
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Evolution of Whipple's Disease
- ClinicalTrials.gov ID
- NCT06776484
- Acronym / sponsor ID
- WHIP / 29BRC24.0315 - WHIP
- Conditions
- Whipple Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Jan 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.
Whipple's disease (WD), a rare systemic infection by Tropheryma whipplei, lacks research on biological abnormalities pre- and post-treatment. This study explores these abnormalities for their diagnostic and monitoring value.
Detailed description
Whipple's disease (WD) is a rare systemic infection caused by *Tropheryma whipplei*. Despite advancements in diagnosis through PCR and biopsy, there is limited research comparing biological abnormalities before and after treatment. This study aimed to characterize these abnormalities and evaluate their potential for aiding in diagnosis and monitoring.
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
- Retrospective study of patients hospitalised in Brest who tested positive for Whipple's disease between 2010 and 2024
Key inclusion criteria (2 listed)
- Patients with at least one positive PCR test for Whipple's disease and a retained diagnosis at Brest University Hospital between 2010 and 2024
- Major patient
Key exclusion criteria (4 listed)
- Minors
- No screening test for Whipple's disease
- Opposition to participation
- Protected patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biological changes
Time frame: 1 day
Biological changes (inflammation, liver function tests, haematology, lymphocyte subpopulations) in patients diagnosed with classic, localised or reactive Whipple's disease
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 15 Jan 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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. 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 Whipple Disease, run by University Hospital, Brest 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 2 inclusion and 4 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 15 Jan 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?
Biological changes (time frame: 1 day). 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 15 Jan 2025.