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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOvEE Participants | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test: CA-125 biomarker | Other |
|
|
| 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 |
| 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 |
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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:
Subjects must be willing to comply with study protocol
Exclusion Criteria:
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Women who are 45+ years of age, living in greater Montreal. Women may self-identify and contact the DOvEE Study directly, or be referred from primary care or physicians or specialists.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Gilbert, MD,MSc,FRCOG | Contact | 514 934-1934 | 34049 | lucy.gilbert@mcgill.ca |
| Claudia Martins, PhD | Contact | 514 9341934 | 35249 | claudia.martins@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lucy Gilbert, MD,MSc,FRCOG | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Island Cancer Wellness Centre | Active, not recruiting | Kirkland | Quebec | H9H0C4 | Canada | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22257524 | Background | Gilbert L, Basso O, Sampalis J, Karp I, Martins C, Feng J, Piedimonte S, Quintal L, Ramanakumar AV, Takefman J, Grigorie MS, Artho G, Krishnamurthy S; DOvE Study Group. Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project. Lancet Oncol. 2012 Mar;13(3):285-91. doi: 10.1016/S1470-2045(11)70333-3. Epub 2012 Jan 17. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009361 | Neoplasm Invasiveness |
| D004194 | Disease |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D018394 | CA-125 Antigen |
| ID | Term |
|---|---|
| D009077 | Mucins |
| D009088 | Mucoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Second Test: Transvaginal Ultrasound | Other | -Transvaginal Ultrasound at visit 1, day 1. |
|
| Follow-up phone call | Other | Phone call 6 months after last visit to verify continued health. |
|
| Axion 50 plus |
| Active, not recruiting |
| Laval |
| Quebec |
| H7V2S8 |
| Canada |
| Clinique Familiale Pas-A-Pas | Withdrawn | Montreal | Quebec | H1H 1J6 | Canada |
| Clinique Médicale du Haut-Anjou | Active, not recruiting | Montreal | Quebec | H1M 3M4 | Canada |
| McGill University Health Centre, Royal Victoria Hospital | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| Queen Elizabeth Health Centre | Recruiting | Montreal | Quebec | H4A 3L6 | Canada |
|
| Lachine Hospital | Active, not recruiting | Montreal | Quebec | H8S 3N5 | Canada |
| Clinique du Dr. L. Quintal | Active, not recruiting | Saint-Lambert | Quebec | J4P 2K7 | Canada |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015295 | Antigens, Tumor-Associated, Carbohydrate |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D000939 | Epitopes |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |