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

McGill University8 sites in 1 country13,600 target enrollmentJanuary 2012

ConditionsOvarian Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ovarian Neoplasms
Sponsor: McGill University
Enrollment: 13600
Locations: 8
Primary Endpoint: Proportion of diagnoses in early, curable stage.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

January 2026

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

McGill University

Responsible Party

Principal Investigator

Dr. Lucy Gilbert

Professor, Department of Obstetrics and Gynecology

McGill University

Eligibility Criteria

Inclusion Criteria

•Sign an approved informed consent form (ICF).
•Be ≥ 45 years of age.
•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

Exclusion Criteria

•Previous bilateral salpingo-oophorectomy (BSO)
•Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
•Current bleeding per rectum, not due to haemorrhoids
•Current frank haematuria
•Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol

Outcomes

Primary Outcomes

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.