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Chemoresistance of Trophoblastic Tumors

Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03488901
Acronym
PrediCTTro
Enrollment
72
Registered
2018-04-05
Start date
2018-04-30
Completion date
2018-12-31
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trophoblastic Tumor

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.

Interventions

OTHERchemoresistance signature

to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Transcription profile associated with the resistance to chemotherapy10 monthsThe 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.

Countries

France

Contacts

Primary ContactPierre-Adrien BOLZE, Dr
pierre-adrien.bolze@chu-lyon.fr04 78 86 56 40
Backup ContactFrançois GOLFIER, Pr
francois.golfier@chu-lyon.fr04 78 86 66 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026