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Study of UK Adults With Congenital Adrenal Hyperplasia. (CaHASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00749593
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : June 11, 2012
Sponsor:
Collaborators:
Society for Endocrinology
The Clinical Endocrinology Trust
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date September 8, 2008
First Posted Date September 9, 2008
Last Update Posted Date June 11, 2012
Study Start Date August 2004
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2008)
The anthropometric, metabolic, endocrine and quality of life variables of adults with congenital adrenal Hyperplasia will be compared to reference ranges for the normal population. [ Time Frame: End of Study ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2008)
To identify areas where further research is required and to inform on the day to day management of adults with CAH [ Time Frame: End of study ]
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 Study of UK Adults With Congenital Adrenal Hyperplasia.
Official Title Cross-Sectional Multi-Centre Study of UK Adults With Congenital Adrenal Hyperplasia.
Brief Summary

Congenital Adrenal Hyperplasia (CAH) is one of the commonest inherited diseases, affecting 1:14,200 live births. It is the result of a genetic defect in one of the enzymes (in most cases 21-hydroxylase) required for cortisol biosynthesis, leading to reduced levels of cortisol and aldosterone, increased ACTH concentrations and consequently increased adrenal androgen production. Patients suffer from problems with growth and development and as adults patients may have problems with fertility, virilisation in women, testicular masses in men and both men and women have an impaired quality of life. Patients have to take life-long therapy. Despite its frequency knowledge surrounding the management of adults with CAH remains fairly limited. There has been a lot of work describing the management of children with CAH but to date there is no consensus on how to manage adults. To address this issue a number of adult endocrinologists in the UK under the auspices of the Society for Endocrinology have established a country wide study (CaHASE) to undertake research in order to set standards of care for adult patients with CAH.

In CAH the severity of the symptoms experienced by affected individuals varies depending on the mutation and the genetic background of the individual. The ability to tailor CAH therapy on an individual basis, as determined by the severity of the underlying defect and an understanding of the likely natural history of the disease, is a key goal in clinical management. Correlation of phenotype (clinical status) and genotype (the underlying 21 hydroxylase gene mutation) will facilitate stratification of severity and provide an important contribution to the debate on potential mechanisms of individualised therapy. For instance it may become clear that certain CAH genotypes are associated with specific long term outcomes. In time, this could lead to suggesting different treatment strategies in certain groups. Moreover, genotype data are important if we are to address the relative contribution of environment (e.g. treatment) vs. genetics on long term outcomes.

This multi-centre study aims to:

  1. - Investigate the medical health of adults with congenital adrenal hyperplasia.
  2. - Investigate the relationship between the genotype of the patient and the phenotype.
  3. - Investigate the quality of life of adults with congenital adrenal hyperplasia.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population UK Adults with Congenital Adrenal Hyperplasia
Condition Congenital Adrenal Hyperplasia
Intervention Not Provided
Study Groups/Cohorts CaHASE 1
Adults with CAH
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: June 8, 2012)
25
Original Estimated Enrollment
 (submitted: September 8, 2008)
200
Actual Study Completion Date December 2011
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age over 18
  • Clinical and genetic diagnosis of congenital adrenal hyperplasia

Exclusion Criteria:

  • Pregnant females
  • Under 18
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00749593
Other Study ID Numbers CaHASE STH13503
MREC 04/07/013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
  • Society for Endocrinology
  • The Clinical Endocrinology Trust
Investigators
Study Chair: Richard JM Ross, MD Sheffield Teaching Hospital NHS Foundation Trust
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date June 2012