DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

Last updated: May 1, 2024
Sponsor: McGill University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometrial Cancer

Ovarian Cysts

Neoplasms

Treatment

Follow-up phone call

Blood test: CA-125 biomarker

Second Test: Transvaginal Ultrasound

Clinical Study ID

NCT02296307
CIHR-276061
  • Ages > 45
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 anabdominal 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 doso, 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
  1. Subjects must be willing to comply with study protocol

Exclusion

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 researchprotocol

Study Design

Total Participants: 13600
Treatment Group(s): 3
Primary Treatment: Follow-up phone call
Phase:
Study Start date:
January 01, 2012
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • West Island Cancer Wellness Centre

    Kirkland, Quebec H9H0C4
    Canada

    Site Not Available

  • Axion 50 plus

    Laval, Quebec H7V2S8
    Canada

    Site Not Available

  • Clinique Familiale Pas-A-Pas

    Montreal, Quebec H1H 1J6
    Canada

    Site Not Available

  • Clinique Médicale du Haut-Anjou

    Montreal, Quebec H1M 3M4
    Canada

    Site Not Available

  • Lachine Hospital

    Montreal, Quebec H8S 3N5
    Canada

    Site Not Available

  • McGill University Health Centre, Royal Victoria Hospital

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Queen Elizabeth Health Centre

    Montreal, Quebec H4A 3L6
    Canada

    Active - Recruiting

  • Clinique du Dr. L. Quintal

    St Lambert, Quebec J4P 2K7
    Canada

    Site Not Available

  • Clinique Plein Ciel

    St-Laurent, Quebec H4L 1X7
    Canada

    Site Not Available

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