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Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.
The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .
To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.
The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.
The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methotrexate sensitive | patients with gestational choriocarcinoma cured with methotrexate alone |
| |
| methotrexate resistant | patients with gestational choriocarcinoma not cured with methotrexate alone |
| |
| polychemotherapy sensitive | patients with gestational choriocarcinoma cured with polychemotherapy |
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| polychemotherapy resistant | patients with gestational choriocarcinoma not cured with polychemotherapy |
| |
| hydatidiform moles without malignant transformation | patients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls) |
| |
| placental site trophoblastic tumors | patients with placental site trophoblastic tumors not cured with polychemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemoresistance signature | Other | to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Transcription profile associated with the resistance to chemotherapy | The expression level of 800 genes involved in oncogenesis canonical pathways and immune tolerance will be assessed and correlated with the resistance to single or multiagent chemotherapy. | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with gestational trophoblastic tumors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Adrien BOLZE, Dr | Contact | 04 78 86 56 40 | +33 | pierre-adrien.bolze@chu-lyon.fr |
| François GOLFIER, Pr | Contact | 04 78 86 66 78 | +33 | francois.golfier@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Français de Référence des Maladies Trophoblastiques | Pierre-Bénite | 69495 | France |
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| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011252 | Pregnancy Complications, Neoplastic |
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Formalin fixed and paraffin embedded tissue samples of gestational choriocarcinoma
|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |