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DOvEE - Diagnosing Ovarian & Endometrial Cancer Early (DOvEE)

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ClinicalTrials.gov Identifier: NCT02296307
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Lucy Gilbert, McGill University

Brief 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.

Condition or disease Intervention/treatment
Ovarian Neoplasms Other: Blood test: CA-125 biomarker Other: Second Test: Transvaginal Ultrasound Other: Follow-up phone call

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Study Type : Observational
Estimated Enrollment : 13600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
Study Start Date : January 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
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. 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
  • CA-125 biomarker blood test at visit 1, day 1.
  • CA-125 biomarker blood test at visit 2, week 6.
Other Names:
  • CA125
  • CA 125
  • cancer antigen 125
  • carbohydrate antigen 125

Other: Second Test: Transvaginal Ultrasound
-Transvaginal Ultrasound at visit 1, day 1.

Other: Follow-up phone call
Phone call 6 months after last visit to verify continued health.




Primary Outcome Measures :
  1. Proportion of diagnoses in early, curable stage. [ Time Frame: 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 Outcome Measures :
  1. Number of participants with physical morbidity related to the program as a measure of safety and tolerability [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who are 50+ 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296307


Contacts
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Contact: Lucy Gilbert, MD,MSc,FRCOG 514 934-1934 ext 34049 lucy.gilbert@mcgill.ca
Contact: Claudia Martins, PhD 514 9341934 ext 35249 claudia.martins@mcgill.ca

Locations
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Canada, Quebec
West Island Wellness Centre Not yet recruiting
Kirkland, Quebec, Canada, H9H0C4
Contact: Lucy Gilbert, MD,MSc,FRCOG         
Contact: Claudia Martins, MD, PhD         
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
Place des Aînés Recruiting
Laval, Quebec, Canada, H7V2S8
Contact: Lucy Gilbert, MD,MSc,FRCOG         
Contact: Claudia Martins, MD, PhD         
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
Clinique Familiale Pas-A-Pas Withdrawn
Montreal, Quebec, Canada, H1H 1J6
Clinique Médicale du Haut-Anjou Recruiting
Montreal, Quebec, Canada, H1M 3M4
Contact: Lucy Gilbert, MD,MSc,FRCOG         
Contact: Claudia Martins, MD, PhD         
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
McGill University Health Centre, Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Lucy Gilbert, MD,MSc,FRCOG    514-934-1934 ext 34049    lucy.gilbert@mcgill.ca   
Contact: Claudia Martins, MD, PhD    514-934-1934 ext 36794    claudia.martins@mcgill.ca   
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
Queen Elizabeth Health Centre Completed
Montreal, Quebec, Canada, H4A 3L6
Lachine Hospital Recruiting
Montreal, Quebec, Canada, H8S 3N5
Contact: Lucy Gilbert, MD,MSc,FRCOG         
Contact: Claudia Martins, MD, PhD         
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
Clinic Familiale de St Lambert Recruiting
St Lambert, Quebec, Canada, J4P 1W7
Contact: Lucy Gilbert, MD MSc FRCOG         
Contact: Claudia Martins, MD PhD         
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
Clinique Plein Ciel Recruiting
St-Laurent, Quebec, Canada, H4L 1X7
Contact: Lucy Gilbert, MD,MSc,FRCOG         
Contact: Claudia Martins, MD, PhD         
Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG         
Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Lucy Gilbert, MD,MSc,FRCOG McGill University

Additional Information:
Publications:
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Responsible Party: Dr. Lucy Gilbert, Professor, Department of Obstetrics and Gynecology, McGill University
ClinicalTrials.gov Identifier: NCT02296307     History of Changes
Other Study ID Numbers: CIHR-276061
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

Keywords provided by Dr. Lucy Gilbert, McGill University:
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

Additional relevant MeSH terms:
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Neoplasms
Endometrial Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders