Associated Factors of Ovarian Cancer and Endometrial Cancer in Indonesia. A Study for Developing Artificial-Intelligence-Based Screening Tools
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,905
- 试验地点
- 1
- 主要终点
- Number of People developing endometrial cancer
研究概览
简要总结
The goal of this observational study is to explore the possible associated factors of ovarian cancer and endometrial cancer in Indonesia and develop screening tools that could predict the risk of both types of cancer
The specific objectives of the study are
- Elaborating the situation of ovarian and endometrial cancer in Indonesia
- Exploring the possible clinical, demography and laboratory predictors of these diseases
- Develop artificial-intelligence-based screening tools for both type of cancer based on possible predictors
This study will utilize the patient registry diagnosed with ovarian and endometrial cancer. We assumed that several demography, clinical, and laboratory predictors might possess good screening performance with higher sensitivity and specificity (>80%).
详细描述
Methodology :
This study will involve two different stages
- The first stage will conduct a cohort study to identify the possible predictors of each type of cancer
- The second stage will cover the development of point-of-care testing based on an artificial intelligence model to predict cancer occurrence and prospective testing of the new participants using a diagnostic study method. The tools will predict the current histopathology result and possible future histopathology within one year.
Participants and source of data In the study centre, women with or without gynaecology-associated symptoms underwent gynaecological and pathology assessments to rule out ovarian and endometrial cancer in our study centre were involved. Data is stored digitally and extraction will be done accordingly
Variables and outcome measurement
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with gynaecological symptoms but not limited to
- •Irregular menstruation
- •Heavy bleeding during menstruation
- •pelvic pain
- •vaginal discharge
- •sudden weight loss
- •pain during sexual intercourse
- •Women who underwent routine gynaecological examination
排除标准
- •unable to undergo serial gynaecological follow-up
结局指标
主要结局
Number of People developing endometrial cancer
时间窗: from baseline to twelve month after entering cohort
Number of people developing endometrial cancer diagnosed with gynaecology and pathology assessment
Number of People developing ovarian cancer
时间窗: from baseline to twelve month after entering cohort
Number of people developing ovarian cancer diagnosed with gynaecology and pathology assessment
次要结局
- Screening Performance of Artificial-Intelligence-based Screening tools(from baseline assessment up to one year)
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University