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Clinical Trial NCT06900699 for Gestational Trophoblastic Neoplasias (GTN) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Assiut UniversityClinicopathological Features , Outcomes and Prognostic Factors of High Risk Patients of Gestational Trophoblastic Neoplasia 42
Clinical Trial NCT06900699 is an observational study for Gestational Trophoblastic Neoplasias (GTN) and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2025 and continue until the study accrues 42 participants. Led by Assiut University, this study is expected to complete by 1 April 2027. The latest data from ClinicalTrials.gov was last updated on 28 March 2025.
Brief Summary
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 eff...
Detailed Description
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 specific...Show More
Official Title
Clinico-pathological Features and Outcomes of High Risk Gestational Trophoblastic Neoplasia Patients: an Observational Cross-sectional Study
Conditions
Gestational Trophoblastic Neoplasias (GTN)Publications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- GTN high risk patient
NCT ID Number
Start Date (Actual)
2025-04
Last Update Posted
2025-03-28
Completion Date (Estimated)
2027-04
Enrollment (Estimated)
42
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
high risk GTN patients according WHO classification there is no interventions | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | about5-7 years from jan 2020 to dec 2027 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | about5-7 years from jan 2020 to dec 2027 |
side effect of treatment protocol | about5-7 years from jan 2020 to dec 2027 | |
Identification of number of chemotherapy courses | about5-7 years from jan 2020 to dec 2025 | |
Identification of duration of chemotherapy courses | about5-7 years from jan 2020 to dec 2025 | |
Identification of factors associated with poor prognosis | about5-7 years from jan 2020 to dec 2027 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
Female
• Patients diagnosed as high risk patient according to WHO classification\[10\]
- Adequate clinical data available, including demographic, pathological, and treatment-related details.
- Patients treated at Assuit university women's health hospital within a specified period (e.g., observational study covering period from Jan 2020 till dec 2025).
• Previous Malignancy - Patients with a history of other malignancies that may confound outcomes.
- Non-GTN Gestational Trophoblastic Disease (GTD) - Patients with benign conditions such as complete or partial hydatidiform mole without progression to GTN.
- Pregnant at Diagnosis - Patients diagnosed with GTN during an ongoing pregnancy.
- Severe Comorbidities - Patients with significant non-GTN-related illnesses that could affect survival outcomes (e.g., severe heart, liver, or renal disease)
Assiut University1409 active studies to exploreStudy Responsible Party
Neveen Adel Aness Zakhari, Principal Investigator, resident, Assiut University
Study Central Contact
Contact: Neveen Adel Aness, master degree, +201283658889, [email protected]
No location data.