Adrenocortical carcinoma · 2023-507010-27-00
CUSHMAH - Benefit of steroidogenesis inhibitors in Mild Cushing syndrome (Mild Autonomous Cortisol Secretion): a randomized trial in patients with Primary Bilateral Macronodular Adrenocortical Hyperplasia
- Status
- Authorised (EU CTIS)Approved to run; CTIS does not say whether it is recruiting — ask the site
- Phase
- Phase 3
- Sponsor
- Assistance Publique Hopitaux De Paris
- Registry records
- CTIS 2023-507010-27-00 (Authorised)Registry last updated 2026-03-06
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · age sex · confidence 0.98 | Age ≥ 18 years old | "Age ≥ 18 years old" | |
| inclusion inclusion · logistics · confidence 0.30 | French speaking | "French speaking" | |
| inclusion inclusion · condition · confidence 0.95 | Patient with PBMAH as determined by adrenal imaging (CT-scan and/or MRI) showing multiples bilateral supracentrimetric adrenal nodules | "Patient with PBMAH as determined by adrenal imaging (CT-scan and/or MRI) showing multiples bilateral supracentrimetric adrenal nodules" | |
| inclusion inclusion · lab value · confidence 0.95 | Mild autonomous cortisol secretion: plasma cortisol after 1 mg overnight dexamethasone test > 50 nmol/L | "plasma cortisol after 1 mg overnight dexamethasone test > 50 nmol/L" | |
| inclusion inclusion · lab value · confidence 0.90 | 24 h Urinary free cortisol < 1,5 upper limit of Normal | "24 h Urinary free cortisol < 1,5 upper limit of Normal" | |
| inclusion inclusion · lab value · confidence 0.80 | Adrenal origin of cortisol excess: morning plasma ACTH < 10 pg/ml or between 10 and 20 pg/ml non responsive to CRH stimulation (stimulation < 50 %) | "morning plasma ACTH < 10 pg/ml or between 10 and 20 pg/ml non responsive to CRH stimulation (stimulation < 50 %)" | |
| inclusion inclusion · comorbidity · confidence 0.90 | Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or treated hypertension and/or diabetes that can be treated with antidiabetic treatments (WHO criteria) | "Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or treated hypertension and/or diabetes that can be treated with antidiabetic treatments (WHO criteria)" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | For women of childbearing potential (WOCBP), negative bHCG and highly effective contraception | "For women of childbearing potential (WOCBP), negative bHCG and highly effective contraception" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | For male, an effective method of contraception | "For male, an effective method of contraception" | |
| inclusion inclusion · consent · confidence 0.30 | Signed a written informed consent | "Signed a written informed consent" | |
| inclusion inclusion · logistics · confidence 0.30 | Affiliated to social security regime or an equivalent system | "Affiliated to social security regime or an equivalent system" | |
| exclusion exclusion · condition · confidence 0.95 | Patients with a Cushing syndrome from another causes than PBMAH | "Patients with a Cushing syndrome from another causes than PBMAH" | |
| exclusion exclusion · pregnancy contraception · confidence 0.95 | Pregnancy or breastfeeding women | "Pregnancy or breastfeeding women" | |
| exclusion exclusion · washout · confidence 0.95 | Steroidogenesis inhibitor treatment less than 6 weeks before inclusion | "Steroidogenesis inhibitor treatment less than 6 weeks before inclusion" | |
| exclusion exclusion · life expectancy · confidence 0.80 | Pathology that is life-threatening in the short term (1 year) | "Pathology that is life-threatening in the short term (1 year)" | |
| exclusion exclusion · comorbidity · confidence 0.90 | Patients with major psychiatric disorders that may interfere with the smooth running of the study | "Patients with major psychiatric disorders that may interfere with the smooth running of the study" | |
| exclusion exclusion · logistics · confidence 0.30 | Patients on AME (state medical aid) | "Patients on AME (state medical aid)" | |
| exclusion exclusion · other · confidence 0.30 | Participation to another clinical trial on medicinal products for human use | "Participation to another clinical trial on medicinal products for human use" | |
| exclusion exclusion · condition · confidence 0.95 | Patients with proven primary adrenal insufficiency | "Patients with proven primary adrenal insufficiency" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Under glucocorticoid (systemic or high dose local) treatment | "Under glucocorticoid (systemic or high dose local) treatment" | |
| exclusion exclusion · comorbidity · confidence 0.30 | Contraindication to steroidogenesis inhibitor | "Contraindication to steroidogenesis inhibitor" | |
| exclusion exclusion · comorbidity · confidence 0.30 | Hypersensitivity to the active substance or to one of its excipients | "Hypersensitivity to the active substance or to one of its excipients" | |
| exclusion exclusion · lab value · confidence 0.95 | Uncontrolled diabetes (HBA1c > 9 %) | "Uncontrolled diabetes (HBA1c > 9 %)" | |
| exclusion exclusion · prior therapy · confidence 0.90 | Loop diuretics and thiazide or thiazide-like diuretic that can cause hypokaliemia | "Loop diuretics and thiazide or thiazide-like diuretic that can cause hypokaliemia" | |
| exclusion exclusion · organ function · confidence 0.85 | Patients at high risk of cardiac rhythm disorders with QT/QTc interval > 470ms (for women) and > 450ms (for men) | "Patients at high risk of cardiac rhythm disorders with QT/QTc interval > 470ms (for women) and > 450ms (for men)" | |
| exclusion exclusion · prior therapy · confidence 0.90 | Drugs with a known risk of QT prolongation as listed in https://crediblemeds.org | "Drugs with a known risk of QT prolongation as listed in https://crediblemeds.org" |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
Inclusion criteria: 1. Age ≥ 18 years old 2. French speaking 3. Patient with PBMAH as determined by adrenal imaging (CT-scan and/or MRI) showing multiples bilateral supracentrimetric adrenal nodules 4. Mild autonomous cortisol secretion: plasma cortisol after 1 mg overnight dexamethasone test > 50 nmol/L, 24 h Urinary free cortisol < 1,5 upper limit of Normal 5. Adrenal origin of cortisol excess: morning plasma ACTH < 10 pg/ml or between 10 and 20 pg/ml non responsive to CRH stimulation (stimulation < 50 %) 6. Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or treated hypertension and/or diabetes that can be treated with antidiabetic treatments (WHO criteria) 7. For women of childbearing potential (WOCBP), negative bHCG and highly effective contraception 8. For male, an effective method of contraception 9. Signed a written informed consent 10. Affiliated to social security regime or an equivalent system Exclusion criteria: 1. Patients with a Cushing syndrome from another causes than PBMAH 2. Pregnancy or breastfeeding women 3. Steroidogenesis inhibitor treatment less than 6 weeks before inclusion 4. Pathology that is life-threatening in the short term (1 year) 5. Patients with major psychiatric disorders that may interfere with the smooth running of the study 6. Patients on AME (state medical aid) 7. Participation to another clinical trial on medicinal products for human use 8. Patients with proven primary adrenal insufficiency 9. Under glucocorticoid (systemic or high dose local) treatment 10. Contraindication to steroidogenesis inhibitor 11. Hypersensitivity to the active substance or to one of its excipients 12. Uncontrolled diabetes (HBA1c > 9 %) 13. Loop diuretics and thiazide or thiazide-like diuretic that can cause hypokaliemia 14. Patients at high risk of cardiac rhythm disorders with QT/QTc interval > 470ms (for women) and > 450ms (for men) 15. Drugs with a known risk of QT prolongation as listed in https://crediblemeds.org
Routes in: how this trial is reached and paid for
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Sites (0)
The registry lists no sites. Countries: France.