DOvEE - Diagnosing Ovarian & Endometrial Cancer Early
- Conditions
- Ovarian Neoplasms
- Interventions
- Other: Follow-up phone call
- Registration Number
- NCT02296307
- Lead Sponsor
- McGill University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 13600
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DOvEE Participants Follow-up phone call All symptomatic women who are eligible for participation in the DOvEE trial receive the same interventions: Blood test: CA-125 biomarker at day 1 and week 6-8. Second Test: Transvaginal Ultrasound at day 1. Follow-up Phone Call: Confirms continuing health 6 months after last visit.
- Primary Outcome Measures
Name Time Method Proportion of diagnoses in early, curable stage. 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.
- Secondary Outcome Measures
Name Time Method Number of participants with physical morbidity related to the program as a measure of safety and tolerability Up to 6 weeks To determine the physical morbidity associated with testing symptomatic women for ovarian cancer by CA-125 and transvaginal ultrasound.
Participants will complete the DOvE Program Impact Assessment at Visit 1, and the Impact of Program on Patient's Well-being Questionnaire at Visit 3.
Trial Locations
- Locations (8)
Clinique Familiale Pas-A-Pas
🇨🇦Montreal, Quebec, Canada
Clinique Médicale du Haut-Anjou
🇨🇦Montreal, Quebec, Canada
West Island Cancer Wellness Centre
🇨🇦Kirkland, Quebec, Canada
Axion 50 plus
🇨🇦Laval, Quebec, Canada
Queen Elizabeth Health Centre
🇨🇦Montreal, Quebec, Canada
Lachine Hospital
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre, Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Clinique du Dr. L. Quintal
🇨🇦St Lambert, Quebec, Canada