Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
26
Countries
1
Sites
8
Low-risk gestational trophoblastic neoplasia
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 12 Feb 2020 → ongoing
- Decision date (initial)
- 2024-08-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515434-32-00
- EudraCT number
- 2019-002814-38
- ClinicalTrials.gov
- NCT04396223
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Low-risk gestational trophoblastic neoplasia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10018211 | Gestational trophoblastic tumor NOS | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 3 Quai Des Celestins, Bp 2251 Bp 2251
- City
- Lyon Cedex 02
- Postcode
- 69229
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Benoit YOU
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Annie IUNG
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 26 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Oncologie médicale, 4 Rue De La Chine, 75020, Paris
Hospices Civils De Lyon
Oncologie médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Oncopole Claudius Regaud
Oncologie médicale, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre de Coordination en Cancérologie François Baclesse
Oncologie médicale, 3 Avenue Général Harris, 14076, CAEN
Centre Antoine Lacassagne
Oncologie médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncologie médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut Bergonie
ONCOLOGIE MEDICALE, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Paoli Calmettes
Oncologie médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
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 | 2020-02-12 | 2024-08-06 | 2024-08-06 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | France | Acceptable 2024-08-06
|
2024-08-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-10 | France | Acceptable 2025-01-31
|
2025-01-31 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-09 | France | Acceptable 2025-01-31
|
2025-10-09 |