The French National Reference Centre of GTD

Gestational Trophoblastic Disease Clinical Trial

— French GTDC  

Official title:

The French National Reference Centre of Gestational Trophoblastic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892877
• Other study ID #: 69HCL16_0519
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: September 2, 2016
• Start date: November 1999
• Est. completion date: November 2029

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: François Golfier, Pr
• Phone: (0)4 78 86 66 78
• Email: francois.golfier[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25500
• Est. completion date: November 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Hydatidiform Mole
• Hydatidiform Mole, Invasive
• Neoplasm, Trophoblastic
• Trophoblastic Neoplasms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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