DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

Recruiting

• Conditions: Ovarian Neoplasms

• 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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 13600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

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; 🇨🇦 St Lambert, Quebec, Canada