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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

Tracking Information
First Submitted Date March 12, 2019
First Posted Date April 19, 2019
Last Update Posted Date April 19, 2019
Estimated Study Start Date May 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 15, 2019)
  • 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.
  • 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.
  • 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
  • To study the duration of outbreak during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    the time to healing
  • To study the relapse during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    the number of relapses
  • To study the number of outbreaks during patients' monitoring [ Time Frame: It will be measured within 6 months of enrollment ]
    the number of outbreaks
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 Pityriasis Lichenoides : Anatomo-clinical Aspects and Follow-up
Official Title Pityriasis Lichenoides: Anatomo-clinical Aspects and Follow-up Monocentric Retrospective Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with Pityriasis Lichenoides
Condition Pityriasis Lichenoides
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 15, 2019)
52
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03920696
Other Study ID Numbers APHP180538
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Saskia ORO, Doctor Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2019