DOvE - Diagnosing Ovarian Cancer Early
Conditions
Ovarian Neoplasms
Conditions: official terms
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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Blood test: CA-125 biomarker Type: Other
Name: Second Test: Transvaginal Ultrasound Type: Other
Name: Follow-up phone call Type: Other
Overall Status
Recruiting
Summary
This study hopes to improve early detection of ovarian cancer. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 50 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Sign an approved informed consent form (ICF).

2. Be ≥ 50 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

- Diarrhoea, 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
Locations
Clinique Familiale Pas-A-Pas
Montreal, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD MSc FRCOG
Clinique Médicale du Haut-Anjou
Montreal, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD,MSc,FRCOG
Lachine Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD,MSc,FRCOG
McGill University, Royal Victoria Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD,MSc,FRCOG
Queen Elizabeth Health Centre
Montreal, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD MSc FRCOG
Clinic Familiale de St Lambert
St Lambert, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD MSc FRCOG
Clinique Plein Ciel
St-Laurent, Quebec, Canada
Status: Recruiting
Contact: Lucy Gilbert, MD,MSc,FRCOG
Start Date
January 2012
Completion Date
June 2016
Sponsors
McGill University
Source
McGill University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page