DOvEE - Diagnosing Ovarian & Endometrial Cancer Early
DOvEE
Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
1 other identifier
observational
13,600
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 2, 2024
May 1, 2024
13 years
October 28, 2014
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of diagnoses in early, curable stage.
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.
Up to 3 years
Secondary Outcomes (1)
Number of participants with physical morbidity related to the program as a measure of safety and tolerability
Up to 6 weeks
Study Arms (1)
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.
Interventions
* CA-125 biomarker blood test at visit 1, day 1. * CA-125 biomarker blood test at visit 2, week 6.
-Transvaginal Ultrasound at visit 1, day 1.
Phone call 6 months after last visit to verify continued health.
Eligibility Criteria
Women who are 45+ years of age, living in greater Montreal. Women may self-identify and contact the DOvEE Study directly, or be referred from primary care or physicians or specialists.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
West Island Cancer Wellness Centre
Kirkland, Quebec, H9H0C4, Canada
Axion 50 plus
Laval, Quebec, H7V2S8, Canada
Clinique Familiale Pas-A-Pas
Montreal, Quebec, H1H 1J6, Canada
Clinique Médicale du Haut-Anjou
Montreal, Quebec, H1M 3M4, Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Queen Elizabeth Health Centre
Montreal, Quebec, H4A 3L6, Canada
Lachine Hospital
Montreal, Quebec, H8S 3N5, Canada
Clinique du Dr. L. Quintal
Saint-Lambert, Quebec, J4P 2K7, Canada
Related Publications (1)
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.
PMID: 22257524BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucy Gilbert, MD,MSc,FRCOG
McGill University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
October 28, 2014
First Posted
November 20, 2014
Study Start
January 1, 2012
Primary Completion
January 1, 2025
Study Completion
January 1, 2026
Last Updated
May 2, 2024
Record last verified: 2024-05