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Pityriasis Lichenoides : Anatomo-clinical Aspects and Follow-up (EtudePL)

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ClinicalTrials.gov Identifier: NCT03920696
Recruitment Status : Unknown
Verified February 2019 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Introduction: Pityriasis lichenoides (PL) is an inflammatory dermatitis of undetermined origin consisting of specific papular lesions reflecting an "indolent" lymphoproliferative state.

The current classification is confusing because it mixes semiological and chronological notions.

The objectives of this study are to better describe the clinical, epidemiological, histological, phenotypic and evolutionary aspects of PL in an adult population.

Methods: Investigators will perform a retrospective cohort study including patients with clinical and histological diagnosis of PL from the coding of the Department of Pathology of Henri-Mondor Hospital and from medical records and photographs of lesions if available, between January 2012 and August 2018. A follow-up telephone interviews will also be proposed to each patient to collect evolution data. Photographs will be systematically reviewed as well as cutaneous samples and a genomic analysis will be performed.

Conclusion: Investigators would like to better understand clinical, histological features and evolutionary aspects of PL in an adult population.


Condition or disease
Pityriasis Lichenoides

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pityriasis Lichenoides: Anatomo-clinical Aspects and Follow-up Monocentric Retrospective Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To study clinical Aspects of Pityriasis Lichenoides on a large series of adult patients [ Time Frame: It will be measured within 6 months of enrollment ]
    Epidemiological and and clinical aspect description of the lesions from medical charts and photographs: age, sex, suspected trigger of the disease, past medical history, frequency of necrotic lesions, topography of lesions, fever, altered general conditions, treatment modalities of the flare.


Secondary Outcome Measures :
  1. To study histological features of Pityriasis Lichenoides [ Time Frame: It will be measured within 6 months of enrollment ]
    The histological description will make use of a centralized re-reading of the slides according to a standardized grid (appearance of the epidermis, type and topography of the dermal infiltrate, results of the immunolabelings etc ...). The investigators aim to investigate the frequency of patients with patterns of pityriasis lichenoides mimicking lymphomatoid papulosis or mycosis fungoides and to correlate the histological aspect with clinical lesions.

  2. To study molecular features of Pityriasis Lichenoides [ Time Frame: It will be measured within 6 months of enrollment ]
    number of clone T in the skin and in the blood.

  3. To study the treatment during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    number of patients with need of a prolonged treatment

  4. To study the duration of outbreak during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    the time to healing

  5. To study the relapse during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    the number of relapses

  6. To study the number of outbreaks during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    the number of outbreaks



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with Pityriasis Lichenoides
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with Pityriasis Lichenoides selected from histological coding OT0431, seen at Henri Mondor and with a diagnosis verified from medical records.

Exclusion Criteria:

  • Histological coding error
  • Histological records of patients in care outside Henri Mondor (cases referred for histological expertise only but not seen clinically)
  • Clinical lesions incompatible with Pityriasis Lichenoides according to classically published semiological data
  • Missing or insufficient medical records for data exploitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920696


Contacts
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Contact: Saskia ORO, Doctor +33 1 49 81 25 36 saskia.oro@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Saskia ORO, Doctor Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03920696    
Other Study ID Numbers: APHP180538
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pityriasis Lichenoides;
cutaneous lymphoma
lymphoproliferation
Additional relevant MeSH terms:
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Pityriasis
Pityriasis Lichenoides
Skin Diseases, Papulosquamous
Skin Diseases
Lichenoid Eruptions
Parapsoriasis