DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

McGill University

Status: Enrolling

Conditions: Ovarian Neoplasms

Treatments: Other: Second Test: Transvaginal Ultrasound; Other: Follow-up phone call; Other: Blood test: CA-125 biomarker

Study type: Observational

Funder types: Other

Identifiers

NCT02296307

CIHR-276061

Details and patient eligibility

About

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.

Enrollment: 13,600 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13,600 participants in 1 patient group

DOvEE Participants

Description:

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.

Treatment:

Other: Follow-up phone call

Other: Blood test: CA-125 biomarker

Other: Second Test: Transvaginal Ultrasound