DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

NCT ID: NCT02296307

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

13600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Blood test: CA-125 biomarker

Intervention Type OTHER

* CA-125 biomarker blood test at visit 1, day 1.
* CA-125 biomarker blood test at visit 2, week 6.

Second Test: Transvaginal Ultrasound

Intervention Type OTHER

-Transvaginal Ultrasound at visit 1, day 1.

Follow-up phone call

Intervention Type OTHER

Phone call 6 months after last visit to verify continued health.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Second Test: Transvaginal Ultrasound

-Transvaginal Ultrasound at visit 1, day 1.

Intervention Type OTHER

Follow-up phone call

Phone call 6 months after last visit to verify continued health.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CA125 CA 125 cancer antigen 125 carbohydrate antigen 125

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McGill University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Lucy Gilbert

Professor, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lucy Gilbert, MD,MSc,FRCOG

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West Island Cancer Wellness Centre

Kirkland, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Axion 50 plus

Laval, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Clinique Familiale Pas-A-Pas

Montreal, Quebec, Canada

Site Status WITHDRAWN

Clinique Médicale du Haut-Anjou

Montreal, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

McGill University Health Centre, Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Queen Elizabeth Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Lachine Hospital

Montreal, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Clinique du Dr. L. Quintal

Saint-Lambert, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lucy Gilbert, MD,MSc,FRCOG

Role: CONTACT

514 934-1934 ext. 34049

Claudia Martins, PhD

Role: CONTACT

514 9341934 ext. 35249

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lucy Gilbert, MD,MSc,FRCOG

Role: primary

514-934-1934 ext. 34049

Claudia Martins, MD, PhD

Role: backup

514-934-1934 ext. 36794

Lucy Gilbert, MD MSc FRCOG

Role: primary

Claudia Martins, MD, PhD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22257524 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIHR-276061

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Photoacoustic Imaging of the Ovary
NCT02110277 TERMINATED NA