Improving early detection of ovarian and endometrial cancer
Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
McGill University · NCT02296307
This study is testing if a blood test and ultrasound can help find ovarian and endometrial cancers earlier in women over 45 who have certain symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 13600 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | McGill University (other) |
| Locations | 8 sites (Kirkland, Quebec and 7 other locations) |
| Trial ID | NCT02296307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the early detection of ovarian and endometrial cancers by evaluating the effectiveness of the CA-125 biomarker blood test and transvaginal ultrasound in women experiencing specific symptoms. Participants will be women aged 45 and older who have had symptoms such as bloating, abdominal pain, or increased urinary frequency for at least two weeks but no longer than one year. The study will assess whether earlier surgical intervention after screening can lead to better outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 45 and older who have experienced specific gastrointestinal or urinary symptoms for a duration of at least two weeks.
Not a fit: Patients who do not exhibit the specified symptoms or are younger than 45 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of ovarian and endometrial cancers, potentially improving survival rates.
How similar studies have performed: Other studies have shown promise in using biomarkers and imaging techniques for early cancer detection, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kirkland, Quebec and 7 other locations
- West Island Cancer Wellness Centre — Kirkland, Quebec, Canada (ACTIVE_NOT_RECRUITING)
- Axion 50 plus — Laval, Quebec, Canada (ACTIVE_NOT_RECRUITING)
- Clinique Familiale Pas-A-Pas — Montreal, Quebec, Canada (WITHDRAWN)
- Clinique Médicale du Haut-Anjou — Montreal, Quebec, Canada (ACTIVE_NOT_RECRUITING)
- McGill University Health Centre, Royal Victoria Hospital — Montreal, Quebec, Canada (RECRUITING)
- Queen Elizabeth Health Centre — Montreal, Quebec, Canada (RECRUITING)
- Lachine Hospital — Montreal, Quebec, Canada (ACTIVE_NOT_RECRUITING)
- Clinique du Dr. L. Quintal — Saint-Lambert, Quebec, Canada (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Lucy Gilbert, MD,MSc,FRCOG — McGill University
- Study coordinator: Lucy Gilbert, MD,MSc,FRCOG
- Email: lucy.gilbert@mcgill.ca
- Phone: 514 934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Neoplasms, Aged, Algorithms, CA-125 Antigen/blood*, Chi-Square Distribution, Early Detection of Cancer*, Feasibility Studies, Female