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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high risk GTN patients according WHO classification | there is no interventions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Remission cure rate | 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 |
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Inclusion Criteria:
• Patients diagnosed as high risk patient according to WHO classification[10]
Exclusion Criteria:
• Previous Malignancy - Patients with a history of other malignancies that may confound outcomes.
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all high risk GTN patients at Assiut university women's health hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neveen Adel Aness, master degree | Contact | +201283658889 | neveenadel0409@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Neveen Adel Aness, master degree | Assiut University | Principal Investigator |
| Alaa EL-Din Mahmoud Ismail | Assiut University | Study Director |
| Hisham Ahmed El-Sayed |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23274560 | Background | 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. | |
| 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. | ||
| 28461032 |
| Label | URL |
|---|---|
| Website for a linked papers and articles | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Not available at moment | papers | View IPD |
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| Overall survival rate. | 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 | 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 | 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 |
| Assiut University |
| Study Director |
| Mostafa Mohammed Ahmed | Assiut University | Study Director |
| 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. |
| 39674133 | 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. |
| 20728069 | 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. |
| 19269684 | 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. |
| 39128338 | 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. |
| 17482245 | 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. |
| 20673583 | 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. |
| 14763174 | 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. |
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