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Neoplasm, TrophoblasticFrench GTDCNCT02892877

The French National Reference Centre of GTD

An observational study of Neoplasm, Trophoblastic and Gestational Trophoblastic Disease, run by Hospices Civils de Lyon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Any age, women only
How many people
25,500 participants
Where
1 siteFrance
Study dates
Nov 1999to Nov 2029
How long will I take part?
18 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient diagnosed with trophoblastic disease

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Centre des Maladies Trophoblastiques Centre Hospitalier Lyon Sud-Bâtiment 3B-2ème étage, 165 Chemin du Grand Revoyet

    Pierre-Bénite, 69495

    François Golfier, Pr, (0)4 78 86 66 78 ext. +33, francois.golfier@chu-lyon.fr

    Touria Hajri, (0)4 78 86 66 78 ext. +33, touria.hajri@chu-lyon.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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
Keywords
Complete Hydatidiform mole, Partial Hydatidiform mole, Invasive mole, Choriocarcinoma, Post-molar neoplasia, Placental Site Trophoblastic Tumor (PSTT), Epithelioid Trophoblastic Tumor (ETT), hCG follow-up
Medical subject headings
Trophoblastic Neoplasms, Gestational Trophoblastic Disease, Hydatidiform Mole, Hydatidiform Mole, Invasive, Choriocarcinoma, Trophoblastic Tumor, Placental Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02892877
Study groupRoleWhat they receive
Complete Hydatidiform mole and Partial Hydatidiform moleNot described
Invasive moleNot described
ChoriocarcinomaNot described
Post-molar neoplasiaNot described
Placental Site Trophoblastic and Epithelioid TumorNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study startNov 1999
  3. Primary completionNov 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25,500 participants (estimated)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02892877
Sponsor's protocol ID
69HCL16_0519
Acronym
French GTDC
Status last verified
Aug 2016
First submitted
2 Aug 2016
Last updated
8 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasm, Trophoblastic and Gestational Trophoblastic Disease, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François Golfier, Pr ((0)4 78 86 66 78 ext. +33, francois.golfier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement (yes or no) between local and pathologists in case of diagnosis of trophoblastic deseases (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.

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