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

March 22, 2025 updated by: Neveen Adel Aness Zakhari, Assiut University

Clinico-pathological Features and Outcomes of High Risk Gestational Trophoblastic Neoplasia Patients: an Observational Cross-sectional Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all high risk GTN patients at Assiut university women's health hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
high risk GTN patients according WHO classification
there is no interventions

What is the study measuring?

Primary 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 Frame: about5-7 years from jan 2020 to dec 2027
time from treatment initiation to disease progression ,relapse ,or death from any cause
about5-7 years from jan 2020 to dec 2027

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission cure rate
Time Frame: 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.
about5-7 years from jan 2020 to dec 2027
Overall survival rate.
Time Frame: 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.
about5-7 years from jan 2020 to dec 2027
Recurrence (Relapse)rate
Time Frame: 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.
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
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
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
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
about5-7 years from jan 2020 to dec 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Neveen Adel Aness, master degree, Faculty of Medicine Assuit University
  • Study Director: Alaa EL-Din Mahmoud Ismail, Faculty of Medicine Assuit University
  • Study Director: Hisham Ahmed El-Sayed, Faculty of Medicine Assuit University
  • Study Director: Mostafa Mohammed Ahmed, Faculty of Medicine Assuit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 22, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTN high risk patient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. papers
    Information identifier: Not available at moment
    Information comments: Most of thé informations available at This site and Google Scholar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gestational Trophoblastic Neoplasias (GTN)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe