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The French National Reference Centre of GTD (French GTDC)

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ClinicalTrials.gov Identifier: NCT02892877
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: The French National Reference Centre of Gestational Trophoblastic Disease
Study Start Date : November 1999
Estimated Primary Completion Date : November 2029
Estimated Study Completion Date : November 2029


Group/Cohort
Complete Hydatidiform mole and Partial Hydatidiform mole
Invasive mole
Choriocarcinoma
Post-molar neoplasia
Placental Site Trophoblastic and Epithelioid Tumor



Primary Outcome Measures :
  1. Agreement (yes or no) between local and pathologists in case of diagnosis of trophoblastic deseases [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed with trophoblastic disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892877


Contacts
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Contact: François Golfier, Pr (0)4 78 86 66 78 ext +33 francois.golfier@chu-lyon.fr
Contact: Touria Hajri (0)4 78 86 66 78 ext +33 touria.hajri@chu-lyon.fr

Locations
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France
Centre des Maladies Trophoblastiques Centre Hospitalier Lyon Sud-Bâtiment 3B-2ème étage, 165 Chemin du Grand Revoyet Recruiting
Pierre-Bénite, France, 69495
Contact: François Golfier, Pr    (0)4 78 86 66 78 ext +33    francois.golfier@chu-lyon.fr   
Contact: Touria Hajri    (0)4 78 86 66 78 ext +33    touria.hajri@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: François Golfier, Pr Centre National de Référence des maladies trophoblastiques Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02892877    
Other Study ID Numbers: 69HCL16_0519
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
Complete Hydatidiform mole
Partial Hydatidiform mole
Invasive mole
Choriocarcinoma
Post-molar neoplasia
Placental Site Trophoblastic Tumor (PSTT)
Epithelioid Trophoblastic Tumor (ETT)
hCG follow-up
Additional relevant MeSH terms:
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Hydatidiform Mole
Gestational Trophoblastic Disease
Hydatidiform Mole, Invasive
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications