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临床试验/NCT05496517
NCT05496517Unknown不适用

Ovarian Cancer Individualized Scoring System (OCISS) for Prediction of Ovarian Cancer Prognosis

Assiut University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年11月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
2
主要终点
Cancer-specific survival (CSS) rate at 5 years

研究概览

简要总结

This project aims at creating an individualized prognostic model using patient characteristics and disease features to determine disease prognosis using machine learning technology. The model can be used to determine the optimal management plan per patient in priori and highlight risk and timing of disease recurrence.

详细描述

Ovarian cancer (OC) is one of the most common types of malignant tumors and the eighth cause of cancer-related mortality in women.[1] Among gynecological cancers, it is ranked the third following cervical and uterine cancers and is associated with the worst prognosis

[1]. Globally, there are 313,959 new cases and 207,252 deaths of OC annually [1].

Compared to breast cancer, OC is approximately three times more lethal [2]. The high mortality rate of OC is attributed to the capacious anatomical space through which the tumor can grow before it causes significant symptoms, growth of the tumor within abdominal cavity rendering spread of malignant cells widespread and prompt, direct lymphatic drainage to aortic lymph nodes, lack of specific diagnostic symptoms, and unavailability of an efficient screening strategy [3,4]. Symptoms of OC are nonspecific and include vague abdominal pain, abdominal bloating, urinary frequency, early satiety, feeling full, or changes in bowel habits, most of which mimic common gastrointestinal symptoms [5]. Risk factors of OC include obesity, old age, smoking, genetic predisposition, and endometriosis [6,7]. FIGO staging is considered the standard classification system that determines prognosis and management of newly diagnosed OC. However, there are numerous gaps in this staging system that would limit interpretation of clinically relevant data [8]. For instance, the staging system does not consider crucial disease prognostic factors, such as histological type and grade, which are usually considered separately based on available evidence and internal policies. This multi-layer guidance adds to the complexity of decision making. Similarly, personalized management is overlooked since these staging systems do not appreciate individual characteristics such as age, menopausal states, comorbidities, and genetic predisposition. All patients with positive lymph nodes are grouped into a single stage in FIGO staging system, which creates a very diverse group of patients with highly variable survival rates [9]. Management of ovarian cancer is surgical and comprises bilateral sapling-oophorectomy, total abdominal hysterectomy , and infracolic omentectomy. Additional surgical steps and neoadjuvant therapy are potentially determined by disease characteristics. Extent of surgery and neoadjuvant treatment is directly related to postoperative comorbidities and contributes to long term prognosis.

[10]. Therefore, development of an individualized prognostic and decision-making system, based on large multicenter studies, would facilitate accurate prediction of disease prognosis and determination of individualized management strategy.

The study will comprise at least 8 international cancer centers. Data of patients, newly diagnosed with OC between January 2010 and December 2016, will be retrospectively collected. Therefore, a follow-up of at least 5 years would be granted. All women who will be diagnosed with primary ovarian cancer at any stage, of all histological types and grades eligible for the study. All contributing centers should acquire institutional review board (IRB) approval prior to data collection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with ovarian cancer between January 2010 and December
  • Primary non-recurrent diagnosis of ovarian cancer.
  • Women should be diagnosed and managed by the corresponding center.
  • Patients with adequate clinical and pathological data

排除标准

  • • Inadequate information and follow-up for at least 5 years.
  • Authorization to use anonymous patient data for research purposes.

结局指标

主要结局

Cancer-specific survival (CSS) rate at 5 years

时间窗: Within 5 years after diagnosis of ovarian cancer

Percentage of women newly diagnosed with ovarian cancer who do not die from ovarian cancer after 5 years

Cancer-specific survival (CSS) rate at 3 years

时间窗: Within 3 years after diagnosis of ovarian cancer

Percentage of women newly diagnosed with ovarian cancer who do not die from ovarian cancer after 3 years

次要结局

  • Recurrence-free survival (RFS) rate at 3 years(Within 3 years of diagnosis of ovarian cancer)
  • Recurrence-free survival (RFS) rate at 5 years(Within 5 years of diagnosis of ovarian cancer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherif Abdelkarim Mohammed Shazly

Assistant lecturer

Assiut University

研究点 (2)

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