NCT05743933

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Feb 2023

Longer than P75 for all trials

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 Progress36%
Feb 2023Feb 2033

First Submitted

Initial submission to the registry

February 16, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2033

Last Updated

September 24, 2026

Status Verified

November 1, 2025

Enrollment Period

10 years

First QC Date

February 16, 2023

Last Update Submit

September 22, 2026

Conditions

Keywords

Diagnosis and differential diagnosisTreatment and prognosisAdrenogenic Autonomic Cortisol Secretion

Outcome Measures

Primary Outcomes (1)

  • SUVmax value of PET-CT

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

    10 years

Secondary Outcomes (1)

  • Etiology and pathogenesis of adrenogenic autonomic cortisol secretion

    10 years

Study Arms (2)

Study group

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

Control group

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with adrenal incidentaloma and serum cortisol \> 50nmol/L after 1mg dexamethasone inhibition test, without other situation mentioned in exclusion criteria.

You may qualify if:

  • CT examination revealed adrenal nodules (maximum diameter ≥10mm);
  • Serum cortisol \> 50nmol/L after 1mg dexamethasone inhibition test (1mg-DST).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Sichuan-Chongqing Joint Key Laboratory of Metabolic Vascular Diseases, Chongqing Key Laboratory of Translational Medicine in Major Metabolic Diseases, The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (3)

  • Jing Y, Hu J, Luo R, Mao Y, Luo Z, Zhang M, Yang J, Song Y, Feng Z, Wang Z, Cheng Q, Ma L, Yang Y, Zhong L, Du Z, Wang Y, Luo T, He W, Sun Y, Lv F, Li Q, Yang S. Prevalence and Characteristics of Adrenal Tumors in an Unselected Screening Population : A Cross-Sectional Study. Ann Intern Med. 2022 Oct;175(10):1383-1391. doi: 10.7326/M22-1619. Epub 2022 Sep 13.

  • Prete A, Subramanian A, Bancos I, Chortis V, Tsagarakis S, Lang K, Macech M, Delivanis DA, Pupovac ID, Reimondo G, Marina LV, Deutschbein T, Balomenaki M, O'Reilly MW, Gilligan LC, Jenkinson C, Bednarczuk T, Zhang CD, Dusek T, Diamantopoulos A, Asia M, Kondracka A, Li D, Masjkur JR, Quinkler M, Ueland GA, Dennedy MC, Beuschlein F, Tabarin A, Fassnacht M, Ivovic M, Terzolo M, Kastelan D, Young WF Jr, Manolopoulos KN, Ambroziak U, Vassiliadi DA, Taylor AE, Sitch AJ, Nirantharakumar K, Arlt W; ENSAT EURINE-ACT Investigators*; ENSAT EURINE-ACT Investigators. Cardiometabolic Disease Burden and Steroid Excretion in Benign Adrenal Tumors : A Cross-Sectional Multicenter Study. Ann Intern Med. 2022 Mar;175(3):325-334. doi: 10.7326/M21-1737. Epub 2022 Jan 4.

  • Deutschbein T, Reimondo G, Di Dalmazi G, Bancos I, Patrova J, Vassiliadi DA, Nekic AB, Debono M, Lardo P, Ceccato F, Petramala L, Prete A, Chiodini I, Ivovic M, Pazaitou-Panayiotou K, Alexandraki KI, Hanzu FA, Loli P, Yener S, Langton K, Spyroglou A, Kocjan T, Zacharieva S, Valdes N, Ambroziak U, Suzuki M, Detomas M, Puglisi S, Tucci L, Delivanis DA, Margaritopoulos D, Dusek T, Maggio R, Scaroni C, Concistre A, Ronchi CL, Altieri B, Mosconi C, Diamantopoulos A, Iniguez-Ariza NM, Vicennati V, Pia A, Kroiss M, Kaltsas G, Chrisoulidou A, Marina LV, Morelli V, Arlt W, Letizia C, Boscaro M, Stigliano A, Kastelan D, Tsagarakis S, Athimulam S, Pagotto U, Maeder U, Falhammar H, Newell-Price J, Terzolo M, Fassnacht M. Age-dependent and sex-dependent disparity in mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: an international, retrospective, cohort study. Lancet Diabetes Endocrinol. 2022 Jul;10(7):499-508. doi: 10.1016/S2213-8587(22)00100-0. Epub 2022 May 6.

Biospecimen

Retention: SAMPLES WITH DNA

Some subtye of disease should be diagnosed by DNA

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qifu Li, PhD

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shumin Yang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 24, 2023

Study Start

February 17, 2023

Primary Completion (Estimated)

February 15, 2033

Study Completion (Estimated)

February 15, 2033

Last Updated

September 24, 2026

Record last verified: 2025-11

Locations