Gestational Trophoblastic Disease Clinical Trial
Official title:
The French National Reference Centre of Gestational Trophoblastic Disease
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
n/a
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01630954 -
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole
|
Phase 4 | |
Completed |
NCT00003702 -
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
|
Phase 3 | |
Completed |
NCT01535053 -
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
|
Phase 3 | |
Completed |
NCT00190918 -
A Trial for Patients With Gestational Trophoblastic Disease
|
Phase 2 | |
Recruiting |
NCT03785574 -
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
|
N/A | |
Completed |
NCT01984099 -
RCT on the Efficacy of Methotrexate for the Prevention of GTD
|
Phase 3 | |
Not yet recruiting |
NCT05637892 -
A Cohort Study of Hydatidiform Mole
|