Cohort Study of Adrenogenic Autonomic Cortisol Secretion

Sponsor
Chongqing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05743933
Collaborator
(none)
200
120

Study Details

Study Description

Brief Summary

To investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in Chinese adults.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. In our previous study, 18.9% of AI were accompanied by autonomic cortisol secretion (ACS) in Chinese. The vast majority of ACS is mild (MACS). Due to the lack of typical Cushing manifestations and the low rate of progression to overt Cushing, MACS has received insufficient attention in the past. However, recent studies have found that MACS have a higher incidence of diabetes, hypertension, cardiovascular events, metabolic bone disease and mortality risk than those with non-functional adenomas. With appropriate treatment, the complications of MACS patients can be effectively improved. However, personalized treatment of MACS is a clinical difficulty. It is hard to determine whether the cortisol secretion of patients is caused by AI or whether patients will benifit from operation. There are some retrospective studies have provided some evidence, while prospective studies are lacking. The purpose of this study is to prospectively include patients with autonomic cortisol secretion, evaluate function and diagnosis, develop personalized treatment strategy, and follow up the prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenogenic autonomic cortisol secretion in the future.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Cohort Study of Adrenogenic Autonomic Cortisol Secretion
    Anticipated Study Start Date :
    Feb 17, 2023
    Anticipated Primary Completion Date :
    Feb 15, 2033
    Anticipated Study Completion Date :
    Feb 15, 2033

    Arms and Interventions

    Arm Intervention/Treatment
    Study group

    Accidental adrenal tumor with 1mg-DST cortisol >50nmol/L

    Control group

    Accidental adrenal tumor with 1mg-DST cortisol ≤50nmol/L

    Outcome Measures

    Primary Outcome Measures

    1. SUVmax value of PET-CT [10 years]

      To explore the value of 68[Ga]-Pentixafor PET-CT in the diagnosis of MACS

    Secondary Outcome Measures

    1. Etiology and pathogenesis of adrenogenic autonomic cortisol secretion [10 years]

      To study the etiology and pathogenesis of adrenogenic autonomic cortisol secretion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • CT examination revealed adrenal nodules (maximum diameter ≥10mm);

    • Serum cortisol > 50nmol/L after 1mg dexamethasone inhibition test (1mg-DST).

    Exclusion Criteria:
    • Patients with primary aldosteronism (PA), pheochromocytoma, adrenal metastatic carcinoma, congenital adrenal hyperplasia (CAH), ganglionic neuroma/paraganglioma, schwannoma, adrenal hematoma and those with no definite diagnosis were evaluated by clinical and endocrine function.

    • Patients with serious underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamic-pituitary-adrenal axis (HPA axis); Pregnancy.

    • Patients with a history of alcoholism, fatigue, trauma, infection, depression, glucocorticoid use, and other drugs affecting the function of the hypothalamic-pituitary-adrenal axis.

    • Patients who are not willing to participate in and complete this study refuse to sign the written informed consent for this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chongqing Medical University

    Investigators

    • Principal Investigator: Qifu Li, PhD, First Affiliated Hospital of Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qifu Li, Prof., Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT05743933
    Other Study ID Numbers:
    • AC-China 2023
    First Posted:
    Feb 24, 2023
    Last Update Posted:
    Feb 24, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Qifu Li, Prof., Chongqing Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2023