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.
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
- Conditions the study is for
- Neoplasm, Trophoblastic, Gestational Trophoblastic Disease, Hydatidiform Mole
- 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
- 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
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
- Conditions
- Neoplasm, Trophoblastic, Gestational Trophoblastic Disease, Hydatidiform Mole, Hydatidiform Mole, Invasive
- 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 group | Role | What they receive |
|---|---|---|
| Complete Hydatidiform mole and Partial Hydatidiform mole | Not described | |
| Invasive mole | Not described | |
| Choriocarcinoma | Not described | |
| Post-molar neoplasia | Not described | |
| Placental Site Trophoblastic and Epithelioid Tumor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted8 Sep 2016 (estimated)
- Study startNov 1999
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, TrophoblasticStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Golfier, Pr, Principal investigator, Centre National de Référence des maladies trophoblastiques Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The French National Reference Centre of Gestational Trophoblastic Disease
- ClinicalTrials.gov ID
- NCT02892877
- Acronym / sponsor ID
- French GTDC / 69HCL16_0519
- Conditions
- Neoplasm, Trophoblastic, Gestational Trophoblastic Disease, Hydatidiform Mole, Hydatidiform Mole, Invasive
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 1999
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Complete Hydatidiform mole and Partial Hydatidiform mole | – | – |
| Invasive mole | – | – |
| Choriocarcinoma | – | – |
| Post-molar neoplasia | – | – |
| Placental Site Trophoblastic and Epithelioid Tumor | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient diagnosed with trophoblastic disease
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Golfier, Pr principal investigator
Centre National de Référence des maladies trophoblastiques Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
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.