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

NCT06900699 | Not Yet Recruiting DMC

• 1 other identifier: GTN high risk patient
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Trophoblastic Neoplasias (GTN)

Outcome Measures

Primary Outcomes (1)

• progression-free survival (time from treatment initiation to disease progression ,relapse ,or death from any cause)

  time from treatment initiation to disease progression ,relapse ,or death from any cause

  about5-7 years from jan 2020 to dec 2027

Secondary Outcomes (7)

• Remission cure rate

  about5-7 years from jan 2020 to dec 2027

• Overall survival rate.

  about5-7 years from jan 2020 to dec 2027

• Recurrence (Relapse)rate

  about5-7 years from jan 2020 to dec 2027

• 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

Study Arms (1)

high risk GTN patients according WHO classification

there is no interventions

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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.

  PMID: 23274560 BACKGROUND

• 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.

  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.

  PMID: 28461032 BACKGROUND

• 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.

  PMID: 39674133 BACKGROUND

• 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.

  PMID: 20728069 BACKGROUND

• 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.

  PMID: 19269684 BACKGROUND

• 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.

  PMID: 39128338 BACKGROUND

• 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.

  PMID: 17482245 BACKGROUND

• 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.

  PMID: 20673583 BACKGROUND

• 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.

  PMID: 14763174 BACKGROUND

Related Links

• Website for a linked papers and articles
• Search engine that incluses files and papers similair or linked to this subject

Study Officials

• Neveen Adel Aness, master degree

  Assiut University

  PRINCIPAL INVESTIGATOR

• Alaa EL-Din Mahmoud Ismail

  Assiut University

  STUDY DIRECTOR

• Hisham Ahmed El-Sayed

  Assiut University

  STUDY DIRECTOR

• Mostafa Mohammed Ahmed

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Neveen Adel Aness, master degree

CONTACT

+201283658889; neveenadel0409@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share