Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Gestational Trophoblastic Disease

Trophoblastic Neoplasms

Hydatidiform Mole

Choriocarcinoma

Nevus

Hydatidiform Mole, Invasive

Trophoblastic Tumor, Placental Site

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

François Golfier, Pr

Touria Hajri

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

The French National Reference Centre of GTD

The French National Reference Centre of Gestational Trophoblastic Disease

trophoblastic deseases can be partial or complete molal pregnancy, choriocarcinoma, , placental site trophoblastic tumors (PSTT), epithelioid trophoblastic tumors (ETT), atypical placental site nodule.

Hospices Civils de Lyon

Gestational Trophoblastic Tumor

Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.

Laboratory Biomarker Analysis

Therapeutic Conventional Surgery

Raymond Osborne

This phase II trial studies how well a second curettage (removal of the abnormal cancer cells in the uterus using a method of surgically removing the lining of the uterus) works in treating patients with gestational trophoblastic tumors that did not go away after a first curettage (persistent) and has not yet spread to other places in the body (non-metastatic). A second curettage may be effective in treating persistent gestational trophoblastic tumors and may decrease the likelihood that patients will need chemotherapy in the near future.

PRIMARY OBJECTIVES:

I. To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).

SECONDARY OBJECTIVES:

I. To evaluate if response to a second curettage is independent of the tumor burden as measured by the quantitative beta-human chorionic gonadotropin (hCG) assay at study entry.

II. To evaluate if response to a second curettage is independent of the depth of myometrial invasion as measured sonographically following the initial curettage but prior to study entry (when persistent disease is first diagnosed).

III. To estimate the frequency of complications related to a second curettage, specifically infection of the fallopian tubes or ovaries, hemorrhage associated with curettage, or operative injury to the uterus.

IV. To estimate the frequency of a change in the uterine histology between the first and second curettage.

OUTLINE:

Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.

After completion of study treatment, patients are followed up at 14 days, weekly for 4 weeks, and then monthly for 5 months, and then every 3 months for 24 months.

Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors

A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia

The frequency and severity of the reported adverse effects of repeat evacuation will be tabulated. Specifically, uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes and ovaries) will be prospectively collected.

National Cancer Institute (NCI)

Gynecologic Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The French National Reference Centre of GTD	NCT02892877	Neoplasm, Troph... Gestational Tro... Hydatidiform Mo... Hydatidiform Mo...		-	Hospices Civils de Lyon
Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors	NCT00521118	Complete Hydati... Non-Metastatic ... Partial Hydatid...	Laboratory Biom... Therapeutic Con...	-	GOG Foundation

Spots Global Cancer Trial Database for complete hydatidiform mole