The French National Reference Centre of GTD
French GTDC
1 other identifier
observational
25,500
1 country
1
Brief Summary
The French Gestational Trophoblastic Disease (GTD) centre has been set up and active by registering, monitoring and treating women with GTD since november 1999. The aim is to improve the management of trophoblastic disease in France. About 850 new cases are registered each year and 140 women treated, mostly with chemotherapy and surgery. The center works as follow, based on a multidisciplinary approach. The policy is that patient remains followed by her local physician, but can be seen and treated in the Center at demand and that the registry is done on a voluntary basis. Each administrative french area has a local expert team (oncologist and gynaecologist) who is able to look after the patients with the help of the national reference center physicians based in Lyon.
- Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement of his patient, for an opinion, an advice or simply to report the case.
- The center sends to the doctor the informed consent form to be signed by the patient, a registering form and information about pathology for patient and physician, and first guidelines based on initial pathology report. The patient remains followed by her gynecologist, who stays her first interlocutor throughout the whole process and she goes to her local laboratory for hCG monitoring;
- A letter is sent to the initial pathology laboratory that originally carried the diagnosis of molar pregnancy to require slide sending to the pathologist referral center (9 experts with a specific pathologist national network) that centrally review initial diagnosis.
- In the mean time, the data manager collects weekly hCG values to establish a follow-up chart. The physician is regularly informed by mail of the hCG evolution.
- The local physician is contacted in case of modification of the diagnosis by the pathologist expert. The center informs him about length and monitoring methodology.
- Emails or letters are sent at each step of the management (at inclusion, at hCG negativation, and at the end of hCG follow-up).
- In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if a neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT), physician is immediately contacted by phone or email by referent gynaecologist. A complete work up including pelvic US with Doppler, pelvic MRI, thoraco-abdominal CT-scan with chest radiography if pulmonary nodules are present and brain MRI, is planned to determine the adequate treatment. Very briefly, based on imaging results, FIGO stade and score are calculated to determine the risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is started in case of high-risk disease. The investigators have developped specific expertise at key levels of diagnosis, management, follow-up, fertility preservation and treatment. Assignments :
- Registration and monitoring post diagnosis of complete or partial molar pregnancy, choriocarcinoma,PSTT, ETT, atypical placental site nodules
- Histopathological analysis and genetics services
- Measurement of human chorionic gonadotrophin (hCG) isoforms
- Complex gynaecological surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 1999
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
September 8, 2016
August 1, 2016
30 years
August 2, 2016
September 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement (yes or no) between local and pathologists in case of diagnosis of trophoblastic deseases
trophoblastic deseases can be partial or complete molal pregnancy, choriocarcinoma, , placental site trophoblastic tumors (PSTT), epithelioid trophoblastic tumors (ETT), atypical placental site nodule.
18 months
Study Arms (5)
Complete Hydatidiform mole and Partial Hydatidiform mole
Invasive mole
Choriocarcinoma
Post-molar neoplasia
Placental Site Trophoblastic and Epithelioid Tumor
Eligibility Criteria
Patient diagnosed with trophoblastic disease
You may qualify if:
- Patients are eligible if they have a histologically proven trophoblastic disease, or a diagnosis of gestational trophoblastic neoplasia done on an abnormal evolution of hCG
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre des Maladies Trophoblastiques Centre Hospitalier Lyon Sud-Bâtiment 3B-2ème étage, 165 Chemin du Grand Revoyet
Pierre-Bénite, 69495, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Golfier, Pr
Centre National de Référence des maladies trophoblastiques Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
September 8, 2016
Study Start
November 1, 1999
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
September 8, 2016
Record last verified: 2016-08