Ovarian Neoplasms
Conditions
Keywords
Aged, Algorithms, CA-125 Antigen/blood*, Chi-Square Distribution, Early Detection of Cancer*, Feasibility Studies, 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
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.
Interventions
OTHERBlood test: CA-125 biomarker
* CA-125 biomarker blood test at visit 1, day 1. * CA-125 biomarker blood test at visit 2, week 6.
OTHERSecond Test: Transvaginal Ultrasound
-Transvaginal Ultrasound at visit 1, day 1.
OTHERFollow-up phone call
Phone call 6 months after last visit to verify continued health.
Sponsors
McGill University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of diagnoses in early, curable stage. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with physical morbidity related to the program as a measure of safety and tolerability | 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. |
Countries
Canada
Contacts
Primary ContactLucy Gilbert, MD,MSc,FRCOG
Backup ContactClaudia Martins, PhD
Outcome results
None listed