临床试验/NCT02296307

NCT02296307招募中不适用

Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women

McGill University8 个研究点分布在 1 个国家目标入组 13,600 人开始时间: 2012年1月最近更新: 2024年5月2日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: McGill University
入组人数: 13,600
试验地点: 8
主要终点: Proportion of diagnoses in early, curable stage.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study hopes to improve early detection of ovarian and endometrial cancers. It will determine if women with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency and/or early satiety, benefit from earlier surgery after screening by CA-125 ovarian cancer biomarker and transvaginal ultrasound.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 45 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Sign an approved informed consent form (ICF).
•Be ≥ 45 years of age.
•Have at least one symptom outlined in below for a period of ≥2 weeks but ≤ 1 year:
•Feeling full after eating only a few bites, loss of appetite
•Diarrhea, constipation, bowel or rectum feels full, change in bowel habits, constant urge to have a bowel movement, painful or burning bowel movements, rectal pain, painful defecation
•Bloating, distension of abdomen, clothes around the waist feel too tight, feel an abdominal mass
•Weight loss not because of dieting
•Nausea, vomiting, heartburn, gas, burping, indigestion
•Increased urinary frequency, need to urinate urgently, pressure on the bladder, leaking urine, burning sensation when urinating, need to urinate but unable to do so, unable to empty bladder completely, feeling full after urinating
•Vaginal discharge, bleeding, spotting, deep pain on intercourse
•Discomfort or pain in abdomen, or pelvic region, or lower back
•Subjects must be willing to comply with study protocol

排除标准

•Previous bilateral salpingo-oophorectomy (BSO)
•Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
•Current bleeding per rectum, not due to haemorrhoids
•Current frank haematuria
•Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol

结局指标

主要结局

Proportion of diagnoses in early, curable stage.

时间窗: Up to 3 years

To determine whether the provision of fast-track diagnostic evaluation of symptomatic women ≥50 years will result in a higher proportion of ovarian cancer, including high-grade serous cancers (HGSCs), diagnosed in low-volume, completely resectable stage.

次要结局

Number of participants with physical morbidity related to the program as a measure of safety and tolerability(Up to 6 weeks)

研究者

发起方

McGill University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Dr. Lucy Gilbert

Professor, Department of Obstetrics and Gynecology

McGill University

研究点 (8)

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