Clinical trial · Observational
DOvEE - Diagnosing Ovarian & Endometrial Cancer Early
Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
NCT02296307CI-TRIAL-00076674DOvEEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood test: CA-125 biomarker | Other | — | UNRESOLVED |
| Follow-up phone call | Other | — | UNRESOLVED |
| Second Test: Transvaginal Ultrasound | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- DOvEE Participants
- description
- 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.
- interventionNames
- Other: Blood test: CA-125 biomarker
- Other: Second Test: Transvaginal Ultrasound
- Other: Follow-up phone call
Primary outcomes (1)
- measure
- Proportion of diagnoses in early, curable stage.
- timeFrame
- Up to 3 years
- description
- 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 outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDGilbert 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. PMID 22257524