Ovarian NeoplasmsDOvEENCT02296307
DOvEE - Diagnosing Ovarian & Endometrial Cancer Early
An observational study of Ovarian Neoplasms, run by McGill University at 8 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Blood test: CA-125 biomarker, Second Test: Transvaginal Ultrasound and Follow-up phone call
- How many people
- 13,600 participants
- Where
- 8 sitesCanada
- Study dates
- Jan 2012to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
- 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
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- 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
- Subjects must be willing to comply with study protocol
Who cannot join
- Previous bilateral salpingo-oophorectomy (BSO)
- Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
- Current bleeding per rectum, not due to haemorrhoids
- Current frank haematuria
- Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites, 2 recruiting
- Active, not recruiting
West Island Cancer Wellness Centre
Kirkland, Quebec, H9H0C4
- Active, not recruiting
Axion 50 plus
Laval, Quebec, H7V2S8
- Withdrawn
Clinique Familiale Pas-A-Pas
Montreal, Quebec, H1H 1J6
- Active, not recruiting
Clinique Médicale du Haut-Anjou
Montreal, Quebec, H1M 3M4
- Recruiting
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Lucy Gilbert, MD,MSc,FRCOG, 514-934-1934 ext. 34049, lucy.gilbert@mcgill.ca
Claudia Martins, MD, PhD, 514-934-1934 ext. 36794, claudia.martins@mcgill.ca
- Recruiting
Queen Elizabeth Health Centre
Montreal, Quebec, H4A 3L6
Lucy Gilbert, MD MSc FRCOG
Claudia Martins, MD, PhD
- Active, not recruiting
Lachine Hospital
Montreal, Quebec, H8S 3N5
- Active, not recruiting
Clinique du Dr. L. Quintal
Saint-Lambert, Quebec, J4P 2K7
About this study
Official title: Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
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.
- Conditions
- Ovarian Neoplasms
- Being tested
- Blood test: CA-125 biomarker, Second Test: Transvaginal Ultrasound, Follow-up phone call
- 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
- Medical subject headings
- Ovarian Neoplasms, Neoplasm Invasiveness, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test: CA-125 biomarkerOther
Also called CA125, CA 125, cancer antigen 125, carbohydrate antigen 125
- CA-125 biomarker blood test at visit 1, day 1.
- CA-125 biomarker blood test at visit 2, week 6.
Second Test: Transvaginal UltrasoundOther
-Transvaginal Ultrasound at visit 1, day 1.
Follow-up phone callOther
Phone call 6 months after last visit to verify continued health.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood test: CA-125 biomarker; Other: Second Test: Transvaginal Ultrasound; Other: Follow-up phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (1)
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lucy Gilbert, McGill University
- Investigators
- Lucy Gilbert, MD,MSc,FRCOG, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296307
- Sponsor's protocol ID
- CIHR-276061
- Acronym
- DOvEE
- Status last verified
- May 2024
- First submitted
- 28 Oct 2014
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22257524
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
- ClinicalTrials.gov ID
- NCT02296307
- Acronym / sponsor ID
- DOvEE / CIHR-276061
- Conditions
- Ovarian Neoplasms
- Keywords
- Aged, Algorithms, CA-125 Antigen/blood*, Chi-Square Distribution, Early Detection of Cancer*, Feasibility Studies, Female, Humans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,600 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOvEE Participants | – | Other: Blood test: CA-125 biomarker, Other: Second Test: Transvaginal Ultrasound, Other: Follow-up phone callAll 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- Previous bilateral salpingo-oophorectomy (BSO)
- Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
- Current bleeding per rectum, not due to haemorrhoids
- Current frank haematuria
- Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test: CA-125 biomarkerAlso: CA125, CA 125, cancer antigen 125, carbohydrate antigen 125* CA-125 biomarker blood test at visit 1, day 1. * CA-125 biomarker blood test at visit 2, week 6. | Other | DOvEE Participants |
| Second Test: Transvaginal Ultrasound-Transvaginal Ultrasound at visit 1, day 1. | Other | DOvEE Participants |
| Follow-up phone callPhone call 6 months after last visit to verify continued health. | Other | DOvEE Participants |
Primary outcome
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.
1 secondary outcome
Number of participants with physical morbidity related to the program as a measure of safety and tolerability
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 22257524Gilbert 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Gilbert, MD,MSc,FRCOG principal investigator
McGill University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by McGill University at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Gilbert, MD,MSc,FRCOG (514 934-1934 ext. 34049, lucy.gilbert@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of diagnoses in early, curable stage. (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.