Clinical trial NCT06900699: Clinicopathological Features , Outcomes and Prognostic Factors of High Risk Patients of Gestational Trophoblastic Neoplasia
Official title: Clinico-pathological Features and Outcomes of High Risk Gestational Trophoblastic Neoplasia Patients: an Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gestational Trophoblastic Neoplasias (GTN)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all high risk GTN patients at Assiut university women's health hospital

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.

Eligibility criteria: 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)

Primary outcomes:
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
Secondary outcomes:
measure: Remission cure rate
timeFrame: about5-7 years from jan 2020 to dec 2027
measure: Overall survival rate.
timeFrame: about5-7 years from jan 2020 to dec 2027
measure: Recurrence (Relapse)rate
timeFrame: about5-7 years from jan 2020 to dec 2027
measure: side effect of treatment protocol
timeFrame: about5-7 years from jan 2020 to dec 2027
measure: Identification of number of chemotherapy courses
timeFrame: about5-7 years from jan 2020 to dec 2025
measure: Identification of duration of chemotherapy courses
timeFrame: about5-7 years from jan 2020 to dec 2025
measure: Identification of factors associated with poor prognosis
timeFrame: about5-7 years from jan 2020 to dec 2027
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Neveen Adel Aness, master degree
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Alaa EL-Din Mahmoud Ismail
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Hisham Ahmed El-Sayed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mostafa Mohammed Ahmed
role: STUDY_DIRECTOR
References:
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citation: RATANAKAEW 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.
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citation: Liu 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.
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citation: Gu 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.
citation: Palmieri C, Dhillon T, Fisher RA, Young AM, Short D, Mitchell H, Aghajanian C, Savage PM, Newlands ES, Hancock BW, Seckl MJ. Management and outcome of healthy women with a persistently elevated beta-hCG. Gynecol Oncol. 2007 Jul;106(1):35-43. doi: 10.1016/j.ygyno.2007.01.053. Epub 2007 May 4.
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citation: Ngan HY, Bender H, Benedet JL, Jones H, Montruccoli GC, Pecorelli S; FIGO Committee on Gynecologic Oncology. Gestational trophoblastic neoplasia, FIGO 2000 staging and classification. Int J Gynaecol Obstet. 2003 Oct;83 Suppl 1:175-7. doi: 10.1016/s0020-7292(03)90120-2. No abstract available.