French GTDC: The French National Reference Centre of GTD

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT02892877

Collaborator

(none)

25,500

Enrollment

Location

360

Duration (Months)

70.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasm, Trophoblastic Gestational Trophoblastic Disease Hydatidiform Mole Hydatidiform Mole, Invasive

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

25500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The French National Reference Centre of Gestational Trophoblastic Disease

Study Start Date :

Nov 1, 1999

Anticipated Primary Completion Date :

Nov 1, 2029

Anticipated Study Completion Date :

Nov 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Complete Hydatidiform mole and Partial Hydatidiform mole
Invasive mole
Choriocarcinoma
Post-molar neoplasia
Placental Site Trophoblastic and Epithelioid Tumor

Outcome Measures

Primary Outcome Measures

Agreement (yes or no) between local and pathologists in case of diagnosis of trophoblastic deseases [18 months]
trophoblastic deseases can be partial or complete molal pregnancy, choriocarcinoma, , placental site trophoblastic tumors (PSTT), epithelioid trophoblastic tumors (ETT), atypical placental site nodule.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre des Maladies Trophoblastiques Centre Hospitalier Lyon Sud-Bâtiment 3B-2ème étage, 165 Chemin du Grand Revoyet	Pierre-Bénite		France	69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: François Golfier, Pr, Centre National de Référence des maladies trophoblastiques Centre Hospitalier Lyon Sud - Hospices Civils de Lyon