RECRUITINGOBSERVATIONAL
DOvEE - Diagnosing Ovarian & Endometrial Cancer Early
Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Sign an approved willing to sign a consent form 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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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
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.
Locations (8)
West Island Cancer Wellness Centre
Kirkland, Quebec, Canada
Axion 50 plus
Laval, Quebec, Canada
Clinique Familiale Pas-A-Pas
Montreal, Quebec, Canada
Clinique Médicale du Haut-Anjou
Montreal, Quebec, Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada
Queen Elizabeth Health Centre
Montreal, Quebec, Canada
Lachine Hospital
Montreal, Quebec, Canada
Clinique du Dr. L. Quintal
Saint-Lambert, Quebec, Canada