Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias
NCT03135769
Gestational Trophoblastic Neoplasias (GTN)
Bordeaux, France
View Trial DetailsNCT Number: NCT06900699
Aim of the Study This study aims to investigate the clinical and pathological features, treatment outcomes, and prognostic factors in high-risk patients with Gestational Trophoblastic Neoplasia (GTN).
Objectives:
* Identify common clinical and pathological features of high-risk GTN patients. * Required surgical treatment as primary or subsequent line. * Evaluate how well different treatments work and their side effects. * Find factors that can help predict patient outcomes. * Compare survival rates and relapse risks among patients.
Trial opening soon.
Get NotifiedFemale
Observational
Gestational trophoblastic disease (GTD) and gestational trophoblastic neoplasm (GTN) encompass a heterogeneous family of rare diseases that originate from fetal trophoblast cells during or after pregnancy. These diseases include benign processes with malignant potential (hydatidiform molar pregnancy) and malignancies including choriocarcinoma (CCA) and intermediate trophoblastic tumors (PSTT, ETT) . GTN more specifically includes hydatidiform molar pregnancies that have undergone malignant transformation, as well as CCA, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT) . The International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO) have developed a staging and scoring system for patients with complete and partial hydatidiform molar pregnancies that have undergone malignant transformation and CCA .The scoring system is prognostic and helps guide initial treatment selection: patients with low-risk disease (i.e., a WHO score from 0 to 6) are treated with single-agent methotrexate (MTX) or dactinomycin, while patients with high-risk disease (i.e., a WHO score 7-12) are treated with multiagent regimens and ultra-high risk group; where risk score ≥12are treated with EMA-CO Despite advances in diagnosis and treatment, high-risk GTN remains a significant clinical challenge, particularly in predicting treatment response and long-term prognosis. Identifying key prognostic factors is crucial to improving therapeutic strategies and optimizing patient outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: about5-7 years from jan 2020 to dec 2027
time from treatment initiation to disease progression ,relapse ,or death from any cause
Time frame: about5-7 years from jan 2020 to dec 2027
refers to the percentage of patients who achieve complete remission, meaning the disappearance of all signs of disease, as a result of treatment. It indicates the proportion of patients who no longer show detectable evidence of the disease and remain disease-free for a specified period.
Time frame: about5-7 years from jan 2020 to dec 2027
is the percentage of patients in a study or treatment group who are still alive after a defined period, regardless of the cause of death. It is commonly used in clinical research to measure the effectiveness of a treatment.
Time frame: about5-7 years from jan 2020 to dec 2027
defined as the reappearance of gestational trophoblastic neoplasia (GTN) after achieving complete remission, indicated by rising hCG levels, radiological evidence of disease, or clinical symptoms following treatment completion.
Time frame: about5-7 years from jan 2020 to dec 2027
Time frame: about5-7 years from jan 2020 to dec 2025
Time frame: about5-7 years from jan 2020 to dec 2025
Time frame: about5-7 years from jan 2020 to dec 2027
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Clinico-pathological Features and Outcomes of High Risk Gestational Trophoblastic Neoplasia Patients: an Observational Cross-sectional Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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