An observational study in Gestational Trophoblastic Neoplasias (GTN), sponsored by Assiut University. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Assiut University · Observational
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:
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.
57 studies on the registry are indexed under Gestational Trophoblastic Disease; 16 are open to participants now.
This study's planned enrollment of 42 is below the median of 150 across 13 observational studies indexed under Gestational Trophoblastic Disease.
Browse Gestational Trophoblastic Disease studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
all high risk GTN patients at Assiut university women's health hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients diagnosed as high risk patient according to WHO classification[10]
Exclusion Criteria:
Previous - Patients with a history of other malignancies that may confound outcomes.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
there is no interventions
progression-free survival (time from treatment initiation to disease progression ,relapse ,or death from any cause)
time from treatment initiation to disease progression ,relapse ,or death from any cause
Time frame: about5-7 years from jan 2020 to dec 2027
Remission cure rate
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
Overall survival rate.
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
Recurrence (Relapse)rate
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
side effect of treatment protocol
Time frame: about5-7 years from jan 2020 to dec 2027
Identification of number of chemotherapy courses
Time frame: about5-7 years from jan 2020 to dec 2025
Identification of duration of chemotherapy courses
Time frame: about5-7 years from jan 2020 to dec 2025
Identification of factors associated with poor prognosis
Time frame: about5-7 years from jan 2020 to dec 2027
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Gestational Trophoblastic Disease →