Clinical trial · Observational
Clinicopathological Features , Outcomes and Prognostic Factors of High Risk Patients of Gestational Trophoblastic Neoplasia
Clinico-pathological Features and Outcomes of High Risk Gestational Trophoblastic Neoplasia Patients: an Observational Cross-sectional Study
NCT06900699CI-TRIAL-00087802not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Gestational Trophoblastic Neoplasias (GTN) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- high risk GTN patients according WHO classification
- description
- there is no interventions
Primary outcomes (1)
- measure
- progression-free survival (time from treatment initiation to disease progression ,relapse ,or death from any cause)
- timeFrame
- about5-7 years from jan 2020 to dec 2027
- description
- time from treatment initiation to disease progression ,relapse ,or death from any cause
Secondary outcomes (7)
- measure
- Remission cure rate
- timeFrame
- about5-7 years from jan 2020 to dec 2027
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * • 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). Exclusion Criteria: * • 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)
References
Publications (10)
- BACKGROUNDHyman DM, Bakios L, Gualtiere G, Carr C, Grisham RN, Makker V, Sonoda Y, Aghajanian C, Jewell EL. Placental site trophoblastic tumor: analysis of presentation, treatment, and outcome. Gynecol Oncol. 2013 Apr;129(1):58-62. doi: 10.1016/j.ygyno.2012.12.029. Epub 2012 Dec 26. PMID 23274560
- BACKGROUNDRATANAKAEW A, WASINGHON P. Prognostic Scoring and Outcome of Gestational Trophoblastic Disease Patients. J Clin Gynecol Obstet North Am. 2023 Aug;12. doi: https://doi.org/10.14740/jcgo876.
- BACKGROUNDKong Y, Yang J, Jiang F, Zhao J, Ren T, Li J, Wang X, Feng F, Wan X, Xiang Y. Clinical characteristics and prognosis of ultra high-risk gestational trophoblastic neoplasia patients: A retrospective cohort study. Gynecol Oncol. 2017 Jul;146(1):81-86. doi: 10.1016/j.ygyno.2017.04.010. Epub 2017 Apr 29. PMID 28461032
- BACKGROUNDLiu YL, Praiss AM, Chiang S, Devereaux K, Huang J, Rizzuto G, Al-Rawi D, Weigelt B, Jewell E, Abu-Rustum NR, Aghajanian C. Gestational trophoblastic neoplasm: Patient outcomes and clinical pearls from a multidisciplinary referral center. Gynecol Oncol. 2025 Jan;192:171-177. doi: 10.1016/j.ygyno.2024.12.009. Epub 2024 Dec 13. PMID 39674133
- BACKGROUNDLurain JR. Gestational trophoblastic disease I: epidemiology, pathology, clinical presentation and diagnosis of gestational trophoblastic disease, and management of hydatidiform mole. Am J Obstet Gynecol. 2010 Dec;203(6):531-9. doi: 10.1016/j.ajog.2010.06.073. Epub 2010 Aug 21. PMID 20728069
- BACKGROUNDEl-Helw LM, Coleman RE, Everard JE, Tidy JA, Horsman JM, Elkhenini HF, Hancock BW. Impact of the revised FIGO/WHO system on the management of patients with gestational trophoblastic neoplasia. Gynecol Oncol. 2009 Jun;113(3):306-11. doi: 10.1016/j.ygyno.2009.02.006. Epub 2009 Mar 9. PMID 19269684
- BACKGROUNDGu Y, Liu Y, Cheng H, Wang W, Xue X, Wan X, Feng F, Yang J, Ren T, Zhao J, Jiang F, Li Y, Xiang Y. Clinicopathological characteristics and oncologic outcomes of patients with gestational trophoblastic neoplasia manifesting as isolated pulmonary lesions. Gynecol Oncol. 2024 Nov;190:28-34. doi: 10.1016/j.ygyno.2024.07.686. Epub 2024 Aug 10.