Clinicopathological Features , Outcomes and Prognostic Factors of High Risk Patients of Gestational Trophoblastic Neoplasia

Assiut University

Status: Not yet enrolling

Conditions: Gestational Trophoblastic Neoplasias (GTN)

Study type: Observational

Funder types: Other

Identifiers

NCT06900699

GTN high risk patient

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 42 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

42 participants in 1 patient group

high risk GTN patients according WHO classification

Description:

there is no interventions