NCT06309498

Brief Summary

The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function. 11-deoxycortisol levels will be assessed in all recruited patients

Trial Health

57
Monitor

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 Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

March 7, 2024

Last Update Submit

March 7, 2024

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • prevalence of RAF

    residual adrenal function

    baseline

Secondary Outcomes (1)

  • prevalence of adrenal crisis

    24 months

Interventions

blood testPROCEDURE

11 DOC levels will be measured in enrolled patients

Also known as: 11 DOC measurement

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adul patients affected with Autoimmune Addison's Disease

You may qualify if:

  • Autoimmune Addison's disease
  • Informed consent

You may not qualify if:

  • \- Drugs affecting immune system or steroids other than hydrocortisone or cortisone acetate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20135, Italy

RECRUITING

Related Publications (2)

  • Pearce SHS, Gan EH, Napier C. MANAGEMENT OF ENDOCRINE DISEASE: Residual adrenal function in Addison's disease. Eur J Endocrinol. 2021 Feb;184(2):R61-R67. doi: 10.1530/EJE-20-0894.

    PMID: 33306039BACKGROUND

  • Vulto A, Bergthorsdottir R, van Faassen M, Kema IP, Johannsson G, van Beek AP. Residual endogenous corticosteroid production in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2019 Sep;91(3):383-390. doi: 10.1111/cen.14006. Epub 2019 Jun 20.

    PMID: 31059146BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Valentina Morelli, PHD

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Morelli, PhD

CONTACT

02619112547v.morelli@auxologico.it

Carmen Aresta, MD

CONTACT

02619112547c.aresta@auxologico.it

Study Design

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

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

January 1, 2023

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)