DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

Study 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.

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

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Other: Blood test: CA-125 biomarker
* Other: Second Test: Transvaginal Ultrasound
* Other: Follow-up phone call


Participation Criteria
=================
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 Discomfort or pain in abdomen, or pelvic region, or lower back Subjects must be willing to comply with study protocol 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DOvEE Participants<br>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<br>* CA-125 biomarker blood test at visit 1, day 1. CA-125 biomarker blood test at visit 2, week 6.<br>* Other names: carbohydrate antigen 125;Other: Second Test: Transvaginal Ultrasound<br>* -Transvaginal Ultrasound at visit 1, day 1.<br>Other: Follow-up phone call<br>* Phone call 6 months after last visit to verify continued health.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of diagnoses in early, curable stage. | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Feasibility Studies, Aged, Algorithms, CA-125 Antigen/blood*, Chi-Square Distribution, Early Detection of Cancer*, Female, Humans, Logistic Models, Mass Screening/methods*, Middle Aged, Neoplasm Grading, Neoplasm Invasiveness, Neoplasm Staging, Ovarian Neoplasms/diagnosis*, Ovarian Neoplasms/epidemiology, Ovarian Neoplasms/immunology, Ovarian Neoplasms/ultrasonography, Pilot Projects, Predictive Value of Tests, Prevalence, Prognosis, Prospective Studies, Quebec/epidemiology, Tumor Burden