PrediCTTro: Chemoresistance of Trophoblastic Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| methotrexate sensitive patients with gestational choriocarcinoma cured with methotrexate alone |
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
|
| methotrexate resistant patients with gestational choriocarcinoma not cured with methotrexate alone |
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
|
| polychemotherapy sensitive patients with gestational choriocarcinoma cured with polychemotherapy |
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
|
| polychemotherapy resistant patients with gestational choriocarcinoma not cured with polychemotherapy |
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
|
| hydatidiform moles without malignant transformation patients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls) |
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
|
| placental site trophoblastic tumors patients with placental site trophoblastic tumors not cured with polychemotherapy |
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Français de Référence des Maladies Trophoblastiques | Pierre-Bénite | France | 69495 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL16_807