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shouyue SUN, MD

Epidemiologic studies have revealed a tremendous increase in the prevalence of adrenal associated disease and related mortality worldwide. In order to meet all the therapeutic challenges in adrenal disease in China, CASE was founded in 2020. The objective of CASE is to launch an adrenal disease management model based on the Internet health information platform which allows the application and evaluation of adrenal disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of adrenal disease, diagnosis, and treatment.

In order to meet all the challenges in the diagnosis and treatment of adrenal diseases in China, CASE was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CASE is committed to creating an online and offline integrated solution for adrenal disease, and for the entire spectrum of adrenal disease, to achieve a more convenient and precise model of care for patients, aiming to establish a platform with diagnosis and treatment of adrenal disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.

China Adrenal Disease Registry

China Adrenal Disease Registry Study

The symptom checklist-90 will be used to evaluate the changes of participants' psychological state through study completion from 10 aspects, including somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, terror, paranoia, psychotic and others.

Shanghai Jiao Tong University School of Medicine

Director, Head of Endocrinology, Principal Investigator, Clinical Professor

Radiofrequency ablation (RFA) is a minimally invasive technique for eliminating both primary tumors and metastases.

The needles that will be used are monopolar RFA, the LeVeen™ Needle Electrode Family with a generator "RF 3000" by Boston Scientific. The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored.

The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored.

Radiofrequency ablation

Béatrice DULY-BOUHANICK, Pr

The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.

The prevalence of hypertension dramatically increased. Although most cases of hypertension are idiopathic, some cases have an identifiable cause. Primary Aldosteronism (PA) is the most common cause of secondary hypertension and can be cured by surgery if PA is due to unilateral unique adrenal adenoma. Then this cause is worth identifying it. The surgery despite its minimally invasive nature is limited by the need for general anesthesia, the risk of vascular or visceral injuries, hematomas and all the adrenal gland is mostly removed. Imaged-guided percutaneous adrenal radiofrequency ablation (ARF) offers a less invasive alternative therapeutic option. This local therapy is employed to treat solid neoplasms whereas its application on functional adrenal adenoma is less documented and only a few case series with limited sample size are published. The impact on blood pressure control is not clearly reported. ARF ablation works by delivering a high-frequency alternating current through a needle electrode. An ionic agitation occurs and generates frictional heat for cell destruction at a predictable temperature and volume. Patients with a conventional documented PA due to unilateral adrenal nod who consented to the study were hospitalized. Patients with PA due to an aldosterone-producing adenoma are included in the study.

Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism

Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.

mean day-time systolic/diastolic blood pressure \<135/85 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment or a decrease of daytime systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months

To assess a decrease of day-time systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months

mean 24 hours systolic/diastolic blood pressure \<130/80 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment

mean day-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months

mean night-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months

mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months

casual systolic blood pressure / diastolic blood pressure \<140/90 mmHg after adrenal radiofrequency ablation, at six months without antihypertensive treatment

decrease of casual systolic blood pressure of 20 mmHg and of casual diastolic blood pressure of 10 mmHg between baseline and 6 months

mean daytime ambulatory blood pressure changes assessed by self-measurement of blood pressure monitoring between baseline and 6 months

number of antihypertensive agents at 6 months after adrenal radiofrequency ablation

evaluation of kalemia at month 1 and month 6

description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation

post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection

cost-effectiveness radiofrequency ablation

University Hospital, Toulouse

Heart and Blood Diseases

Hypertension

Hypokalemia

Potassium Deficiency

Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.

CXCR4

Zhe Meng

The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.

CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism

measure the level of aldosterone in blood

measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal

the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

Zhongnan Hospital

Nervous System Diseases

Cardiac Complexes, Premature

ACTH-Secreting Pituitary Adenoma

Pituitary ACTH Hypersecretion

ACTH Syndrome, Ectopic

Adenocarcinoma

Paraneoplastic Syndromes

ACTH-secreting Pituitary Adenoma

ACTH-independent Macronodular Adrenal Hyperplasia

Adrenocorticotropic Hormone

Patients in this arm took the study drug, osilodrostat.

Osirodrostat 1mg, 5mg \& 10mg in the form of film-coated tablets was used for oral administration.

Osilodrostat

Novartis Pharmaceuticals

The study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.

This was a Phase II, single arm, open-label, dose titration, multi-center study which consisted of two distinct Study Periods plus an optional extension period in non-CD patients with CS. The 3 Study Periods (two distinct Study Periods plus an optional extension period) were as follows:

Study Period I \[Week 0 (Day 1) to Week-12\]: Study Period I was the dose titration period to achieve a stable therapeutic dose and to assess the efficacy and safety of osilodrostat.

The dosing regimen of osilodrostat in this study was titrated according to the following escalation sequence: osilodrostat 2 mg bid, 5 mg bid, 10 mg bid, 20 mg bid, and 30 mg bid. Dose adjustments were based on the serum cortisol values measured by the local lab at each site. Osilodrostat titration was done weekly for the initial 4-weeks, up to a maximum dose of 10 mg bid.

The mean of three 24-hour UFC (mUFC) values were measured to evaluate the efficacy in this period.

Study Period II (After Week-12 to Week-48): Study Period II was the period to assess the sustainability of efficacy and long term safety.

During Study Period II, only patients who tolerated and agreed to continue osilodrostat treatment continued on the study. The patient was administered with the stable therapeutic dose which was achieved in the Study Period I.

Optional extension period (After Week-48): Patients who continued to receive clinical benefit, as assessed by the study Investigator and who wished to enter the extension period were reconsented at Week-48. Patients who entered the extension period continued to be treated with the study drug without interruption to be assessed for efficacy and safety. Patients who continued to benefit from study treatment as assessed by the study investigator and who completed Week-72 were offered to participate in a separate long-term safety follow-up study. The optional extension period ended after all patients had completed Week-72 or had discontinued early.

Post-treatment Follow-up: All patients had 30 days safety follow-up after the last dose of study treatment.

Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome

A Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's Disease

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com

Percent change from baseline in the mUFC at the individual patient level

Absolute change from baseline in the mUFC

Complete response rate = percentage of participants who had mUFC≤ ULN; Partial response rate = Percentage of participants who had mUFC\>ULN and at least 50% reduction from baseline in mUFC. Overall response rate = Percentage of participants who had mUFC ≤ ULN or at least 50% reduction from baseline.

Absolute change from baseline in morning serum cortisol at the individual patient level

Percentage change from baseline in morning serum cortisol at the individual patient level

Absolute change from baseline in several steroid hormones at individual levels: ACTH, Serum 11-deoxycorticosterone, Aldosterone, Estradiol

Percent change from baseline in several steroid hormones at individual levels: ACTH, Serum 11-deoxycorticosterone, Aldosterone, Estradiol

Absolute change from baseline in several steroid hormones at individual levels: Serum 11-deoxycortisol, Testosterone

Percent change from baseline in several steroid hormones at individual levels: Serum 11-deoxycortisol, Testosterone

Absolute change in cardiovascular-related metabolic parameter fasting glucose, associated with Cushing's syndrome (CS)

Percentasge change in cardiovascular-related metabolic parameter fasting glucose, associated with Cushing's syndrome (CS)

Absolute change in cardiovascular-related metabolic parameter HbA1c associated with Cushing's syndrome (CS)

Percentage change in cardiovascular-related metabolic parameter HbA1c associated with Cushing's syndrome (CS)

Absolute change in cardiovascular-related metabolic parameters: cholesterol, HDL cholesterol, LDL cholesterol \& triglycerides, associated with Cushing's syndrome (CS)

Percent change in cardiovascular-related metabolic parameters: cholesterol, HDL cholesterol, LDL cholesterol \& triglycerides, associated with Cushing's syndrome (CS)

Absolute change in cardiovascular-related metabolic parameter: BMI, associated with Cushing's syndrome (CS)

Percent change in cardiovascular-related metabolic parameter: BMI, associated with Cushing's syndrome (CS)

Absolute change in cardiovascular-related metabolic parameter: Waist circumference, associated with Cushing's syndrome (CS)

Percent change in cardiovascular-related metabolic parameter: Waist circumference, associated with Cushing's syndrome (CS)

Absolute change in cardiovascular-related metabolic parameter: sitting systolic BP \& sitting diastolic BP, associated with Cushing's syndrome (CS)

Percentage change in cardiovascular-related metabolic parameter: sitting systolic BP \& sitting diastolic BP, associated with Cushing's syndrome

The Cushing's Disease Health-Related Quality of Life Questionnaire (Cushing QoL) (version 1.0) was developed to evaluate quality of life in patients with Cushing's syndrome (Webb et al 2008). The Cushing QoL is comprised of 12 items that capture patient responses on seven concepts: daily activities, healing and pain, mood and self-confidence, social concerns, physical appearance, memory and concern about the future. Each questionnaire of the Cushing QOL has a scale of 1-5 where '1' corresponding to 'Always' or 'Very much' and '5' to 'Never' or 'Not at all'. The lower the score, the greater the impact on HRQoL. The score is the sum of all the item response and can range from 12 (worst) to 60 points (best).

The Beck Depression Inventory II (BDI-II) is a patient reported instrument that consists of 21 items designed to assess the intensity of depression in clinical \& normal patients in the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each of 21 items corresponds to a symptom of depression and the sum of total score will be calculated where each item has a four-point scale ranging from 0 to 3, leading to a total score from zero to 63.

Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.

AE description; Any sign or symptom that occurs during the study treatment plus the 30 days post treatment

Age, Continuous

Sex: Female, Male

Japanese

Race/Ethnicity, Customized

ACTH-Independent Macronodular Adrena;l Hyperplasia

Adrenal Adenoma

Ectopic Corticotropin Syndrome

Type of disease

Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
China Adrenal Disease Registry	NCT04890444	Cushing Syndrom... Aldosteronism Hypoadrenalism Congenital Adre... Adrenal Adenoma Adrenal Inciden... Adrenal Carcino... Pheochromocytom...		16 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism	NCT02756754	Primary Aldoste... Adrenal Adenoma	Radiofrequency ...	18 Years -	University Hospital, Toulouse
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis	NCT05839483	Aldosterone-Pro...	CXCR4	18 Years - 70 Years	Zhongnan Hospital
China Adrenal Disease Registry	NCT04890444	Cushing Syndrom... Aldosteronism Hypoadrenalism Congenital Adre... Adrenal Adenoma Adrenal Inciden... Adrenal Carcino... Pheochromocytom...		16 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome	NCT02468193	Cushing's Syndr... Ectopic Cortico... Adrenal Adenoma Adrenal Carcino... AIMAH PPNAD	Osilodrostat	18 Years - 85 Years	Novartis
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis	NCT05839483	Aldosterone-Pro...	CXCR4	18 Years - 70 Years	Zhongnan Hospital
Laparoscopic Adrenalectomy for Large Adrenal Tumors.	NCT03830593	Adrenal Tumor Adrenal Adenoma	Laparoscopic Ad...	18 Years - 80 Years	Samsun Liv Hospital
Laparoscopic Adrenalectomy for Large Adrenal Tumors.	NCT03830593	Adrenal Tumor Adrenal Adenoma	Laparoscopic Ad...	18 Years - 80 Years	Samsun Liv Hospital
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks	NCT03374215	Adrenal Gland N... Hypertension Bone Diseases, ... Cardiovascular ... Hyperinsulinemi...		7 Years - 70 Years	National Institutes of Health Clinical Center (CC)
A Prospective Cohort Study for Patients With Adrenal Diseases	NCT03474237	Adrenal Adenoma Cushing Syndrom... Pheochromocytom... Adrenal Inciden... Adrenocortical ... Primary Hyperal...	Hormone study a...	19 Years -	Seoul National University Hospital

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