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

Not yet recruiting

• Conditions: Gestational Trophoblastic Neoplasias (GTN)

• Registration Number: NCT06900699
• Lead Sponsor: Assiut University

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 effects.

* Find factors that can help predict patient outcomes.

* Compare survival rates and relapse risks among patients.

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 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-22
• Last Update Submitted: 2025-03-22
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 42

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival (time from treatment initiation to disease progression ,relapse ,or death from any cause)	about5-7 years from jan 2020 to dec 2027	time from treatment initiation to disease progression ,relapse ,or death from any cause

Secondary Outcome Measures

Name	Time	Method
Remission cure rate	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.
Overall survival rate.	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.
Recurrence (Relapse)rate	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.
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