NCT04903587

Brief Summary

To detect the prevalence of gonadal changes by US among the patients with CAH.

  • assess the patients' radiological findings in relation to their hormonal profile.
  • early management and prevention of complications resulting from possible gonadal dysfunction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

December 30, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 23, 2021

Last Update Submit

December 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of gonadal changes in CAH patients

    By using US and MRI to detect the finding in gonades in CAH patients

    baseline

Interventions

Abdominal Ultrasonography and axial MRI

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

all patients diagnosed with congenital adrenal hyperplasia (CAH)

You may qualify if:

  • All patients diagnosed with CAH between five and 16 years of age will be asked to participate in this cross sectional study.
  • Compliant patients with regular follow up.

You may not qualify if:

  • Presence of other endocrinal diseases or chronic conditions.
  • Female patients with ovulatory dysfunction from other causes including thyroid dysfunction and hyperprolactinemia.
  • Male patients with other diseases causing impairment of gonadal capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Dumic M, Duspara V, Grubic Z, Oguic SK, Skrabic V, Kusec V. Testicular adrenal rest tumors in congenital adrenal hyperplasia-cross-sectional study of 51 Croatian male patients. Eur J Pediatr. 2017 Oct;176(10):1393-1404. doi: 10.1007/s00431-017-3008-7. Epub 2017 Sep 6.

    PMID: 28879515BACKGROUND
  • Chen HD, Huang LE, Zhong ZH, Su Z, Jiang H, Zeng J, Liu JC. Ovarian Adrenal Rest Tumors Undetected by Imaging Studies and Identified at Surgery in Three Females with Congenital Adrenal Hyperplasia Unresponsive to Increased Hormone Therapy Dosage. Endocr Pathol. 2017 Jun;28(2):146-151. doi: 10.1007/s12022-016-9461-4.

    PMID: 28032206BACKGROUND

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Adrenogenital SyndromeDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAdrenal Gland DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Hasnaa Hassan, post gradute

CONTACT

Mohamed Salah Elkholy, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2021

First Posted

May 26, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

December 30, 2021

Record last verified: 2021-05

Locations