Trophoblastic Tumor Clinical Trial
— PrediCTTroOfficial title:
Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors
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.
| Status | Not yet recruiting |
| Enrollment | 72 |
| Est. completion date | December 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - tissue specimen (block/biopsy) not available - degraded quality of tissue sample not compatible with transcriptome analysis (>20% of necrosis) |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Français de Référence des Maladies Trophoblastiques | Pierre-Bénite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |