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Trial record 14 of 16 for:    "Peutz-Jeghers Syndrome"

Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the CARNEY Complex (CNC) (EVACARNEY)

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ClinicalTrials.gov Identifier: NCT00668291
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date April 25, 2008
First Posted Date April 29, 2008
Last Update Posted Date July 6, 2016
Study Start Date January 2008
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2008)
To assess the clinical manifestations of the CARNEY Complex (CNC) and/or the primary pigmented nodular adrenocortical disease (PPNAD) [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00668291 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 28, 2008)
Genotype/phenotype correlation. To determine the frequency of PRKAR1A germline mutation in patients with isolated cardiac myxoma or isolated lentiginosis. [ Time Frame: 6 months ]
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 Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the CARNEY Complex (CNC)
Official Title Assessment of the Clinical Symptoms of the Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the CARNEY Complex (CNC).
Brief Summary Cohort CNC-PPNAD will be investigated with clinical, genetic, biological and imaging work-up every year during 3 years. Cohort L-MC will be investigated clinically at inclusion and a PERKAR1A genotype will be performed.
Detailed Description The primary aim is to assess the clinical manifestations of the CARNEY Complex (CNC) and/or the primary pigmented nodular adrenocortical disease (PPNAD) in patients with CNC, isolated PPNAD or carriers of PRKAR1A and PPNAD1 (PDE11A4) germline mutation (Cohort CNC-PPNAD). In this cohort genotype/phenotype correlation will be studied. A second aim is to determine the frequency of PRKAR1A germline mutation in patients with isolated cardiac myxoma or isolated lentiginosis (Cohort L-MC).
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
2 tubes EDTA 5 mL each (DNA) and 2 tubes heparine 5 mL each (cellular biology)
Sampling Method Non-Probability Sample
Study Population Consultations
Condition
  • Primary; Complex
  • Pigmented Nodular Adrenocortical Disease, Primary, 1
  • Periorificial Lentiginosis
  • Cardiac Myxoma
Intervention Not Provided
Study Groups/Cohorts
  • CNC
    Primary pigmented nodular adrenocortical disease (PPNAD) and the Carney complex (CNC)
  • MC-L
    cardiac myxoma or isolated lentiginosis
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 Completed
Actual Enrollment
 (submitted: July 25, 2012)
133
Original Estimated Enrollment
 (submitted: April 28, 2008)
160
Actual Study Completion Date January 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

CNC group :

  • patient with the CARNEY complex (CNC) or the primary pigmented nodular adrenocortical disease (PPNAD) or a germinal mutation of the gene of CARNEY Complex or PPNAD.
  • No age criteria
  • Inform consent of the patient or the parental authority collected
  • Realization of a preliminary medical examination
  • Affiliated with a social security system ( profit or having right)

MC-L group :

  • Patient with periorificial lentiginosis or cardiac myxoma
  • or previous history of periorificial lentiginosis or cardiac myxoma
  • age > or = 18 years old
  • Realization of a preliminary medical examination
  • Affiliated with a social security system ( profit or having right)

Exclusion criteria :

CNC group and MC-L group:

  • refusal or incapacity to take part in the study
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00668291
Other Study ID Numbers P060251
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Jerome Bertherat, MD PH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2016