NCT06527157招募中不适用
PROspective ACcrual To Investigate reprOductive Cancers in womeN
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- PinkDx, Inc.
- 入组人数
- 4,500
- 试验地点
- 27
- 主要终点
- Sensitivity
研究概览
简要总结
The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
- •Willing and able to comply with scheduled visits, study plan, and other procedures.
- •Expected to be available for the duration of the study and can be contacted by telephone during study participation.
- •Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
- •Presence of uterus.
- •AUB or PMB being worked up to diagnose the cause of the bleeding
排除标准
- •Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members.
- •Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
- •Women who have had a hysterectomy.
- •Women with a known history of endometrial cancer or uterine sarcoma.
- •Women who have received prior treatment for endometrial cancer.
- •Inability or unwillingness to sign informed consent.
- •Clinical suspicion of pregnancy.
- •Women who have used a tampon within 7 days of sample collection.
研究组 & 干预措施
Benign
sample collection from females with benign causes of AUB/PMB
Malignant
sample collection from females with malignant causes of AUB/PMB
结局指标
主要结局
Sensitivity
时间窗: 12 months
ability to detect cancer
次要结局
- Specificity(12 months)
研究者
研究点 (27)
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