DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

Ovarian Neoplasms Clinical Trial

— DOvEE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02296307
• Other study ID #: CIHR-276061
• Status: Recruiting
• Start date: January 2012
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: McGill University
• Contact: Lucy Gilbert, MD,MSc,FRCOG
• Phone: 514 934-1934
• Email: lucy.gilbert[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13600
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Sign an approved informed consent form (ICF).

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:

1. Previous bilateral salpingo-oophorectomy (BSO)

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Neoplasms
• Ovarian Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	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	Lachine Hospital	Montreal	Quebec
Canada	McGill University Health Centre, Royal Victoria Hospital	Montreal	Quebec
Canada	Queen Elizabeth Health Centre	Montreal	Quebec
Canada	Clinique du Dr. L. Quintal	St Lambert	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with physical morbidity related to the program as a measure of safety and tolerability	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.	Up to 6 weeks

External Links

•   DOvE study website