Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
13600 participants
OBSERVATIONAL
2012-01-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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DOvEE Participants
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.
Blood test: CA-125 biomarker
* CA-125 biomarker blood test at visit 1, day 1.
* CA-125 biomarker blood test at visit 2, week 6.
Second Test: Transvaginal Ultrasound
-Transvaginal Ultrasound at visit 1, day 1.
Follow-up phone call
Phone call 6 months after last visit to verify continued health.
Interventions
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Blood test: CA-125 biomarker
* CA-125 biomarker blood test at visit 1, day 1.
* CA-125 biomarker blood test at visit 2, week 6.
Second Test: Transvaginal Ultrasound
-Transvaginal Ultrasound at visit 1, day 1.
Follow-up phone call
Phone call 6 months after last visit to verify continued health.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be ≥ 45 years of age.
3. 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
4. Subjects must be willing to comply with study protocol
Exclusion Criteria
2. Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
3. Current bleeding per rectum, not due to haemorrhoids
4. Current frank haematuria
5. Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol
45 Years
FEMALE
No
Sponsors
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McGill University
OTHER
Responsible Party
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Dr. Lucy Gilbert
Professor, Department of Obstetrics and Gynecology
Principal Investigators
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Lucy Gilbert, MD,MSc,FRCOG
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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West Island Cancer Wellness Centre
Kirkland, Quebec, Canada
Axion 50 plus
Laval, Quebec, Canada
Clinique Familiale Pas-A-Pas
Montreal, Quebec, Canada
Clinique Médicale du Haut-Anjou
Montreal, Quebec, Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada
Queen Elizabeth Health Centre
Montreal, Quebec, Canada
Lachine Hospital
Montreal, Quebec, Canada
Clinique du Dr. L. Quintal
Saint-Lambert, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Lucy Gilbert, MD MSc FRCOG
Role: primary
Claudia Martins, MD, PhD
Role: backup
References
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Gilbert L, Basso O, Sampalis J, Karp I, Martins C, Feng J, Piedimonte S, Quintal L, Ramanakumar AV, Takefman J, Grigorie MS, Artho G, Krishnamurthy S; DOvE Study Group. Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project. Lancet Oncol. 2012 Mar;13(3):285-91. doi: 10.1016/S1470-2045(11)70333-3. Epub 2012 Jan 17.
Other Identifiers
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CIHR-276061
Identifier Type: -
Identifier Source: org_study_id
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