DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

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

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.

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