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

NCT ID: NCT06900699

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Gestational Trophoblastic Neoplasias (GTN)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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high risk GTN patients according WHO classification

there is no interventions

No interventions assigned to this group

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Adel Aness Zakhari

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neveen Adel Aness, master degree

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Alaa EL-Din Mahmoud Ismail

Role: STUDY_DIRECTOR

Assiut University

Hisham Ahmed El-Sayed

Role: STUDY_DIRECTOR

Assiut University

Mostafa Mohammed Ahmed

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Neveen Adel Aness, master degree

Role: CONTACT

+201283658889

References

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Hyman 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.

Reference Type BACKGROUND
PMID: 23274560 (View on PubMed)

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.

Reference Type BACKGROUND

Kong 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.

Reference Type BACKGROUND
PMID: 28461032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39674133 (View on PubMed)

Lurain 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.

Reference Type BACKGROUND
PMID: 20728069 (View on PubMed)

El-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.

Reference Type BACKGROUND
PMID: 19269684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39128338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17482245 (View on PubMed)

Seckl MJ, Sebire NJ, Berkowitz RS. Gestational trophoblastic disease. Lancet. 2010 Aug 28;376(9742):717-29. doi: 10.1016/S0140-6736(10)60280-2. Epub 2010 Jul 29.

Reference Type BACKGROUND
PMID: 20673583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14763174 (View on PubMed)

Study Documents

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Document Type: papers

Most of thé informations available at This site and Google Scholar

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/

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Other Identifiers

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GTN high risk patient

Identifier Type: -

Identifier Source: org_study_id

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