DOvEE - Diagnosing Ovarian & Endometrial Cancer Early (DOvEE)

May 1, 2024 updated by: Dr. Lucy Gilbert, McGill University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

13600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Kirkland, Quebec, Canada, H9H0C4
        • Active, not recruiting
        • West Island Cancer Wellness Centre
      • Laval, Quebec, Canada, H7V2S8
        • Active, not recruiting
        • Axion 50 plus
      • Montreal, Quebec, Canada, H1H 1J6
        • Withdrawn
        • Clinique Familiale Pas-A-Pas
      • Montreal, Quebec, Canada, H1M 3M4
        • Active, not recruiting
        • Clinique Médicale du Haut-Anjou
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre, Royal Victoria Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucy Gilbert, MD,MSc,FRCOG
      • Montreal, Quebec, Canada, H8S 3N5
        • Active, not recruiting
        • Lachine Hospital
      • Montreal, Quebec, Canada, H4A 3L6
        • Recruiting
        • Queen Elizabeth Health Centre
        • Contact:
          • Claudia Martins, MD, PhD
        • Contact:
          • Lucy Gilbert, MD MSc FRCOG
        • Principal Investigator:
          • Lucy Gilbert, MD,MSc,FRCOG
      • St Lambert, Quebec, Canada, J4P 2K7
        • Active, not recruiting
        • Clinique du Dr. L. Quintal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who are 45+ years of age, living in greater Montreal. Women may self-identify and contact the DOvEE Study directly, or be referred from primary care or physicians or specialists.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DOvEE Participants

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.
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.
Other Names:
  • CA125
  • CA 125
  • cancer antigen 125
  • carbohydrate antigen 125
Other: Second Test: Transvaginal Ultrasound
-Transvaginal Ultrasound at visit 1, day 1.
Other: Follow-up phone call
Phone call 6 months after last visit to verify continued health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of diagnoses in early, curable stage.
Time Frame: 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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with physical morbidity related to the program as a measure of safety and tolerability
Time Frame: 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.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Investigators

  • Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG, McGIll University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimated)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR-276061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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