Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
375
Countries
1
Sites
5
malignancy of thyroid nodules
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 17 Jan 2019 → 7 May 2025
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516416-22-00
- EudraCT number
- 2018-001960-45
- ClinicalTrials.gov
- NCT03498183
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
malignancy of thyroid nodules
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Eric MIRALLIE
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Eric MIRALLIE
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 375 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Curie
nuclear medecine, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Lille
Endocrinology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
CHRU De Nancy
endocrinology, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Universitaire De Nantes
Endocrinology, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Hospices Civils De Lyon
Endocrinology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2019-01-17 | 2025-05-07 | 2019-01-17 | 2024-07-17 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | France | Acceptable 2024-09-16
|
2024-10-07 |