Clinical trial · Interventional
Advanced Methods for Cancer Detection by Vaginal Screening
Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection
NCT02622776CI-TRIAL-00037456ADVISEcompletedN/AClinicalTrials.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 pilot study is the first step in the development of an new assay that may be further tested as a screening method for ovarian and endometrial cancers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaginal DNA Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Vaginal DNA Collection
- description
- Patients with a diagnosis of ovarian cancer or endometrial cancer who have not yet had surgery, chemotherapy or radiation may be able eligible to participate. Patients unaffected by cancer may be able to participate.
- interventionNames
- Other: Vaginal DNA Collection
Primary outcomes (2)
- measure
- Assay sensitivity and specificity as assessed by the mutation detection rate in tumour and vaginal DNA
- timeFrame
- 24 months
- description
- Vaginal DNA and tumour DNA will be compared to determine the mutation detection rate of the assay. Vaginal DNA from normal samples will determine if a background rate of somatic mutations is present in healthy women.
- measure
- Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: Ovarian Cancer and Endometrial Cancer cases: 1. Women age 19 or older. 2. Histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial cancer, not yet treated by surgery or chemotherapy. 3. Give consent to access primary tumour tissue following surgery or biopsy. Healthy participants: 1\) Healthy women between the ages of 19 and 60. Exclusion Criteria: Ovarian Cancer and Endometrial Cancer cases: 1. Women with self-reported, known pregnancy. Healthy participants: 2. Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded. 3. Women who report irregular bleeding (spotting between menstrual cycles, or post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are ineligible. 4. Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be eligible to participate as healthy volunteers for this study. 5. Women with self-reported, known pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.