Adrenocortical carcinoma · 2024-517334-18-00
TOASST Study: Taper Or Abrupt Steroid STop?
Glucocorticoid withdrawal and glucocorticoid-induced adrenal insufficiency: a randomized controlled multicenter trial
- Status
- Authorised (EU CTIS)Approved to run; CTIS does not say whether it is recruiting — ask the site
- Phase
- Phase 4
- Sponsor
- Kantonsspital Baden AG
- Registry records
- CTIS 2024-517334-18-00 (Authorised)Registry last updated 2026-06-30
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · consent · confidence 0.30 | Informed Consent as documented by signature | "Informed Consent as documented by signature" | |
| inclusion inclusion · age sex · confidence 0.98 | Age ≥ 18 years | "Age ≥ 18 years" | |
| inclusion inclusion · prior therapy · confidence 0.85 | Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion | "Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion" | |
| inclusion inclusion · prior therapy · confidence 0.30 | Therapy over ≥ 28 days, | "Therapy over ≥ 28 days" | |
| inclusion inclusion · prior therapy · confidence 0.30 | ≥ 7.5 mg prednisone-equivalent average daily dose until time of inclusion, | "≥ 7.5 mg prednisone-equivalent average daily dose until time of inclusion" | |
| inclusion inclusion · prior therapy · confidence 0.30 | cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion | "cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion" | |
| inclusion inclusion · condition · confidence 0.30 | Tapering not or no longer mandatory to treat underlying disease | "Tapering not or no longer mandatory to treat underlying disease" | |
| exclusion exclusion · condition · confidence 0.97 | Primary adrenal failure | "Primary adrenal failure" | |
| exclusion exclusion · pregnancy contraception · confidence 0.30 | Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion. | "Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion." | |
| exclusion exclusion · logistics · confidence 0.30 | Known or suspected non-compliance | "Known or suspected non-compliance" | |
| exclusion exclusion · logistics · confidence 0.30 | Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, | "Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Untreated hereditary galactose intolerance or lactase deficiency or glucose-galactose malabsorption. | "Untreated hereditary galactose intolerance or lactase deficiency or glucose-galactose malabsorption." | |
| exclusion exclusion · washout · confidence 0.30 | Participation in another study with investigational drug within the 30 days preceding and during the present study, | "Participation in another study with investigational drug within the 30 days preceding and during the present study" | |
| exclusion exclusion · other · confidence 0.30 | Previous enrolment into the current study, | "Previous enrolment into the current study" | |
| exclusion exclusion · logistics · confidence 0.30 | Enrolment of the investigator, his/her family members, employees and other dependent persons | "Enrolment of the investigator, his/her family members, employees and other dependent persons" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural) | "Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural)" | |
| exclusion exclusion · other · confidence 0.30 | Incapability to administer glucocorticoid cover treatment in situations of stress | "Incapability to administer glucocorticoid cover treatment in situations of stress" | |
| exclusion exclusion · consent · confidence 0.30 | Inability or unwillingness to provide informed consent | "Inability or unwillingness to provide informed consent" | |
| exclusion exclusion · pregnancy contraception · confidence 0.30 | Women who are pregnant or breast feeding, | "Women who are pregnant or breast feeding" | |
| exclusion exclusion · pregnancy contraception · confidence 0.30 | Intention to become pregnant during the course of the study, | "Intention to become pregnant during the course of the study" |
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. Informed Consent as documented by signature 2. Age ≥ 18 years 3. Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion 4. Therapy over ≥ 28 days, 5. ≥ 7.5 mg prednisone-equivalent average daily dose until time of inclusion, 6. cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion 7. Tapering not or no longer mandatory to treat underlying disease Exclusion criteria: 1. Primary adrenal failure 2. Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion. 3. Known or suspected non-compliance 4. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, 5. Untreated hereditary galactose intolerance or lactase deficiency or glucose-galactose malabsorption. 6. Participation in another study with investigational drug within the 30 days preceding and during the present study, 7. Previous enrolment into the current study, 8. Enrolment of the investigator, his/her family members, employees and other dependent persons 9. Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural) 10. Incapability to administer glucocorticoid cover treatment in situations of stress 11. Inability or unwillingness to provide informed consent 12. Women who are pregnant or breast feeding, 13. Intention to become pregnant during the course of the study,
Routes in: how this trial is reached and paid for
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Sites (0)
The registry lists no sites. Countries: Germany.