Chemoresistance of Trophoblastic Tumors
- Conditions
- Trophoblastic Tumor
- Interventions
- Other: chemoresistance signature
- Registration Number
- NCT03488901
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 72
- confirmed gestational trophoblastic tumor histology
- hCG follow-up of at least 12 months after hCG normalization
- registration in the French Reference Center for Trophoblastic Diseases
- tissue specimen (block/biopsy) not available
- degraded quality of tissue sample not compatible with transcriptome analysis (>20% of necrosis)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description methotrexate resistant chemoresistance signature patients with gestational choriocarcinoma not cured with methotrexate alone polychemotherapy resistant chemoresistance signature patients with gestational choriocarcinoma not cured with polychemotherapy methotrexate sensitive chemoresistance signature patients with gestational choriocarcinoma cured with methotrexate alone placental site trophoblastic tumors chemoresistance signature patients with placental site trophoblastic tumors not cured with polychemotherapy polychemotherapy sensitive chemoresistance signature patients with gestational choriocarcinoma cured with polychemotherapy hydatidiform moles without malignant transformation chemoresistance signature patients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls)
- Primary Outcome Measures
Name Time Method Transcription profile associated with the resistance to chemotherapy 10 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Français de Référence des Maladies Trophoblastiques
🇫🇷Pierre-Bénite, France