Deciphering Aquagenic Pruritus in Myeloproliferaitive NeoplasmsPANAMNCT04018209
Aquagenic Pruritus in Myeloproliferative Neoplasms
An observational study of Deciphering Aquagenic Pruritus in Myeloproliferaitive Neoplasms, run by University Hospital, Brest at 11 sites in France.
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?
- Ages 18 years and older
- Conditions the study is for
- Deciphering Aquagenic Pruritus in Myeloproliferaitive Neoplasms
- How many people
- 170 participants
- Where
- 11 sitesFrance
- Study dates
- 9 Jul 2019to 6 Jan 2021
- 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 one of three Philadelphia positive non-chromosome myeloproliferative neoplasms: polycythemia vera (PV), essential thrombocythemia (TE) or primary myelofibrosis (PMF). And suffering (or having suffered) from aquagenic pruritus.
Who may be able to join
- Patients with one of three non-chromosomal Philadelphia-positive myeloproliferative neoplasms: polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF).
- Suffering (or having suffered) from aquagenic pruritus.
- No age limit, but major
- Patient having formulated his non-opposition
Who cannot join
- Patients with MPN with non-aquagenic pruritus,
- Patients with another hematologic disease and aquagenic pruritus
- Patients unable to complete the questionnaire.
- Patients with physical or mental disabilities to formulate non-opposition
- Refusal of participation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
06
Angers, Pays de la Loire Region, 49000
03
Annecy, Haute-Savoie, 74000
01
Brest, 29609
05
Lyon, Auvergne Rhônes-alpes, 69000
11
Morlaix, Brittany Region, 29600
10
Quimper, Brestagne, 29000
08
Rochefort, New Aquitaine, 17300
04
Roubaix, Hauts-de-France, 59100
09
Saint-Brieuc, Brittany Region, 22000
07
Saint-Louis, Grand Est, 68300
02
Villejuif, Val-de-marne, 94800
About this study
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 French Hospitals. Patients could be followed for polycythemia vera or essential thrombocythemia or primary myelofibrosis.
Distribution of the questionnaire to each patient with myeloproliferative neoplasm (treated or not) suffering from aquagenic pruritus.
Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.
- Keywords
- Pruritus, Myeloproliferative Neoplasms
- Medical subject headings
- Pruritus, Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of pruritus in patients with myeloproliferative neoplasms
Intensity of pruritus (visual analogic scale)
Measured: at the time of questionnaire completion (Day 0)
Secondary outcomes (1)
Description of therapies used to treat pruritus
Name of drugs used
Measured: at the time of questionnaire completion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start9 Jul 2019
- Primary completion9 Jan 2020
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deciphering Aquagenic Pruritus in Myeloproliferaitive NeoplasmsStudies 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
- 170 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
- NCT04018209
- Sponsor's protocol ID
- PANAM (29BRC19.0001)
- Acronym
- PANAM
- Status last verified
- Oct 2024
- First submitted
- 24 May 2019
- Last updated
- 1 Nov 2024
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquagenic Pruritus in Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT04018209
- Acronym / sponsor ID
- PANAM / PANAM (29BRC19.0001)
- Keywords
- Pruritus, Myeloproliferative Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 12 Jul 2019 (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 French Hospitals. Patients could be followed for polycythemia vera or essential thrombocythemia or primary myelofibrosis.
Distribution of the questionnaire to each patient with myeloproliferative neoplasm (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
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with one of three Philadelphia positive non-chromosome myeloproliferative neoplasms: polycythemia vera (PV), essential thrombocythemia (TE) or primary myelofibrosis (PMF). And suffering (or having suffered) from aquagenic pruritus.
Key inclusion criteria (4 listed)
- Patients with one of three non-chromosomal Philadelphia-positive myeloproliferative neoplasms: polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF).
- Suffering (or having suffered) from aquagenic pruritus.
- No age limit, but major
- Patient having formulated his non-opposition
Key exclusion criteria (5 listed)
- Patients with MPN with non-aquagenic pruritus,
- Patients with another hematologic disease and aquagenic pruritus
- Patients unable to complete the questionnaire.
- Patients with physical or mental disabilities to formulate non-opposition
- Refusal of participation
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
Description of pruritus in patients with myeloproliferative neoplasms
Time frame: at the time of questionnaire completion (Day 0)
Intensity of pruritus (visual analogic scale)
1 secondary outcome
Description of therapies used to treat pruritus
Time frame: at the time of questionnaire completion (Day 0)
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 Nov 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deciphering Aquagenic Pruritus in Myeloproliferaitive Neoplasms, run by University Hospital, Brest at 11 sites 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 4 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Description of pruritus in patients with myeloproliferative neoplasms (time frame: at the time of questionnaire completion (Day 0)). 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 Nov 2024.