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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

• 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

⁃ Discomfort or pain in abdomen, or pelvic region, or lower back

• Subjects must be willing to comply with study protocol

Locations
Other Locations
Canada
West Island Cancer Wellness Centre
ACTIVE_NOT_RECRUITING
Kirkland
Axion 50 plus
ACTIVE_NOT_RECRUITING
Laval
Clinique Familiale Pas-A-Pas
WITHDRAWN
Montreal
Clinique Médicale du Haut-Anjou
ACTIVE_NOT_RECRUITING
Montreal
Lachine Hospital
ACTIVE_NOT_RECRUITING
Montreal
McGill University Health Centre, Royal Victoria Hospital
RECRUITING
Montreal
Queen Elizabeth Health Centre
RECRUITING
Montreal
Clinique du Dr. L. Quintal
ACTIVE_NOT_RECRUITING
St Lambert
Contact Information
Primary
Lucy Gilbert, MD,MSc,FRCOG
lucy.gilbert@mcgill.ca
514 934-1934
Backup
Claudia Martins, PhD
claudia.martins@mcgill.ca
514 9341934
Time Frame
Start Date: 2012-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 13600
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: McGill University

This content was sourced from clinicaltrials.gov