Clinical trial · Observational
Chemoresistance of Trophoblastic Tumors
Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Trophoblastic Tumor | Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoresistance signature | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- methotrexate sensitive
- description
- patients with gestational choriocarcinoma cured with methotrexate alone
- interventionNames
- Other: chemoresistance signature
- label
- methotrexate resistant
- description
- patients with gestational choriocarcinoma not cured with methotrexate alone
- interventionNames
- Other: chemoresistance signature
- label
- polychemotherapy sensitive
- description
- patients with gestational choriocarcinoma cured with polychemotherapy
- interventionNames
- Other: chemoresistance signature
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available