Myeloproliferative DisorderPASYMPLENCT03688490
Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms
An observational study of Myeloproliferative Disorder, run by University Hospital, Brest.
Trial summary
Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms. Prospective work based on the distribution of a dedicated questionnaire. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myeloproliferative Disorder
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 17 Jul 2013to 4 Nov 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients followed for myeloproliferative neoplasms in our Institution (Brest University Hospital)
Who may be able to join
- patients followed with myeloproliferative neoplasms
- suffering from aquagenic pruritus
Who cannot join
- Unable to fulfil the questionnaire
- No written informed consent
About this study
Official title: Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)
Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.
Prospective work based on the distribution of a dedicated questionnaire.
Read the detailed description
Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.
Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus.
Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.
- Conditions
- Myeloproliferative Disorder
- Keywords
- aquagenic pruritus
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of the pruritus
Analogic Visual Scale, from 0 to 10, Worse if >6
Measured: 15 days
Secondary outcomes (1)
Duration of the pruritus
Timing expresses in minutes
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start17 Jul 2013
- Primary completion4 Nov 2013
- Study completion4 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative DisorderStudies 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IANOTTO Jean-Christophe, MD, PhD, Principal investigator, Hématologie Clinique-Institut de Cancéro-Hématologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688490
- Sponsor's protocol ID
- PASYMPLE
- Acronym
- PASYMPLE
- Status last verified
- Aug 2018
- First submitted
- 20 Sep 2018
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carre JL, Misery L, Ianotto JC. Clinical characteristics of aquagenic pruritus in patients with myeloproliferative neoplasms. Br J Dermatol. 2017 Jan;176(1):255-258. doi: 10.1111/bjd.14809. Epub 2016 Dec 22. No abstract available.
PubMed 27291777
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)
- ClinicalTrials.gov ID
- NCT03688490
- Acronym / sponsor ID
- PASYMPLE / PASYMPLE
- Conditions
- Myeloproliferative Disorder
- Keywords
- aquagenic pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 Jul 2013 (actual)
- Primary completion
- 4 Nov 2013 (actual)
- Study completion
- 4 Nov 2013 (actual)
- First posted
- 28 Sep 2018 (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.
Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.
Prospective work based on the distribution of a dedicated questionnaire.
Detailed description
Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.
Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus.
Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients followed for myeloproliferative neoplasms in our Institution (Brest University Hospital)
Key inclusion criteria (2 listed)
- patients followed with myeloproliferative neoplasms
- suffering from aquagenic pruritus
Key exclusion criteria (2 listed)
- Unable to fulfil the questionnaire
- No written informed consent
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
Intensity of the pruritus
Time frame: 15 days
Analogic Visual Scale, from 0 to 10, Worse if >6
1 secondary outcome
Duration of the pruritus
Time frame: 15 days
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 1 Jul 2019.
- Results publication: PubMed 27291777Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carre JL, Misery L, Ianotto JC. Clinical characteristics of aquagenic pruritus in patients with myeloproliferative neoplasms. Br J Dermatol. 2017 Jan;176(1):255-258. doi: 10.1111/bjd.14809. Epub 2016 Dec 22. No abstract available.
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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.
IANOTTO Jean-Christophe, MD, PhD principal investigator
Hématologie Clinique-Institut de Cancéro-Hématologie
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Disorder, run by University Hospital, Brest.
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 2 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Intensity of the pruritus (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688490, which also lists 1 linked publication.
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 Jul 2019.