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出境医 / 临床实验 / Aquagenic Pruritus in Myeloproliferative Neoplasms (PANAM)
Aquagenic Pruritus in Myeloproliferative Neoplasms (PANAM)
Study Description
Brief 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.
| Condition or disease |
|---|
| Deciphering Aquagenic Pruritus in Myeloproliferaitive Neoplasms |
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
| Study Type : | Observational |
| Estimated Enrollment : | 125 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Aquagenic Pruritus in Myeloproliferative Neoplasms |
| Actual Study Start Date : | July 9, 2019 |
| Estimated Primary Completion Date : | January 9, 2020 |
| Estimated Study Completion Date : | January 9, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Description of pruritus in patients with myeloproliferative neoplasms [ Time Frame: at the time of questionnaire completion (Day 0) ]Intensity of pruritus (visual analogic scale)
Secondary Outcome Measures :
- Description of therapies used to treat pruritus [ Time Frame: at the time of questionnaire completion (Day 0) ]Name of drugs used
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Jean-Christophe IANOTTO | +33298222523 | jean-Christophe.ianotto@chu-brest.fr | |
| Contact: Laurent MISERY | +33298223315 | laurent.misery@chu-brest.fr |
Locations
| France | |
| 05 | Not yet recruiting |
| Lyon, Auvergne Rhônes-alpes, France, 69000 | |
| Contact: Franck-Emmanuel NICOLINI +33469856193 franc-emmanuel.nicolini@lyon-unicancer.fr | |
| 10 | Not yet recruiting |
| Quimper, Brestagne, France, 29000 | |
| Contact: Pascal HUTIN +33296017123 p.hutin@ch-cornouaille.fr | |
| 11 | Not yet recruiting |
| Morlaix, Bretagne, France, 29600 | |
| Contact: Mohamed MALOU +33298791297 | |
| 09 | Not yet recruiting |
| Saint-Brieuc, Bretagne, France, 22000 | |
| Contact: Anaïg DAGORNE +33296017123 anaig.dagorne@ch-stbrieuc.fr | |
| 07 | Not yet recruiting |
| Saint-Louis, Grand Est, France, 68300 | |
| Contact: Emmanuel RAFFOUX +33142499649 emmanuel.raffoux@aphp.fr | |
| 03 | Not yet recruiting |
| Annecy, Haute-Savoie, France, 74000 | |
| Contact: Pascale CONY-MAKHOUL +33450636431 pconymakhoul@ch-annecygenevois.fr | |
| 04 | Not yet recruiting |
| Roubaix, Hauts-de-France, France, 59100 | |
| Contact: Mathieu WEMEAU +33320993270 mathieu.wemeau@chu-roubaix.fr | |
| 08 | Not yet recruiting |
| Rochefort, Nouvelle Aquitaine, France, 17300 | |
| Contact: Guillaume DENIS +33546885050 guillaume.denis@ch-rochefort.fr | |
| 06 | Not yet recruiting |
| Angers, Pays De La Loire, France, 49000 | |
| Contact: Corentin ORVAIN +33615270461 corentin.orvain@univ.fr | |
| 02 | Not yet recruiting |
| Villejuif, Val-de-marne, France, 94800 | |
| Contact: Laurence LE GROS +33145593620 Laurence.legros@aphp.fr | |
| 01 | Recruiting |
| Brest, France, 29609 | |
| Contact: Jean-Christophe Ianotto jean-christophe.ianotto@chu-brest.fr | |
Sponsors and Collaborators
University Hospital, Brest
| Tracking Information | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 24, 2019 | ||||||||||
| First Posted Date | July 12, 2019 | ||||||||||
| Last Update Posted Date | August 9, 2019 | ||||||||||
| Actual Study Start Date | July 9, 2019 | ||||||||||
| Estimated Primary Completion Date | January 9, 2020 (Final data collection date for primary outcome measure) | ||||||||||
| Current Primary Outcome Measures |
Description of pruritus in patients with myeloproliferative neoplasms [ Time Frame: at the time of questionnaire completion (Day 0) ] Intensity of pruritus (visual analogic scale)
|
||||||||||
| Original Primary Outcome Measures | Same as current | ||||||||||
| Change History | |||||||||||
| Current Secondary Outcome Measures |
Description of therapies used to treat pruritus [ Time Frame: at the time of questionnaire completion (Day 0) ] Name of drugs used
|
||||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Descriptive Information | |||||||||||
| Brief Title | Aquagenic Pruritus in Myeloproliferative Neoplasms | ||||||||||
| Official Title | Aquagenic Pruritus in Myeloproliferative Neoplasms | ||||||||||
| Brief 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. |
||||||||||
| 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 Type | Observational | ||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||
| Biospecimen | Not Provided | ||||||||||
| Sampling Method | Probability Sample | ||||||||||
| 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. |
||||||||||
| Condition | Deciphering Aquagenic Pruritus in Myeloproliferaitive Neoplasms | ||||||||||
| Intervention | Not Provided | ||||||||||
| Study Groups/Cohorts | Not Provided | ||||||||||
| Publications * | Not Provided | ||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||
| Recruitment Status | Recruiting | ||||||||||
| Estimated Enrollment |
125 | ||||||||||
| Original Estimated Enrollment | Same as current | ||||||||||
| Estimated Study Completion Date | January 9, 2020 | ||||||||||
| Estimated Primary Completion Date | January 9, 2020 (Final data collection date for primary outcome measure) | ||||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||||
| Accepts Healthy Volunteers | No | ||||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||||
| Removed Location Countries | |||||||||||
| Administrative Information | |||||||||||
| NCT Number | NCT04018209 | ||||||||||
| Other Study ID Numbers | PANAM (29BRC19.0001) | ||||||||||
| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Brest | ||||||||||
| Study Sponsor | University Hospital, Brest | ||||||||||
| Collaborators | Not Provided | ||||||||||
| Investigators | Not Provided | ||||||||||
| PRS Account | University Hospital, Brest | ||||||||||
| Verification Date | July 2019 | ||||||||||
