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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA082710 | U.S. NIH Grant/Contract | View source | |
| H15-01726 | Other Identifier | UBC BCCA REB |
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Funding has run out
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. The confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.
All subjects will undergo standard management (colposcopy) for their cervical lesion as scheduled. For cervical sites suspicious of dysplasia, acriflavine hydrochloride 0.05% solution will be applied topically, then rinsed with saline prior to in vivo confocal imaging with the hand-held probe. Following that, a biopsy of the suspicious site will be performed irrespective of the confocal microscopy finding. A biopsy of the normal site will be taken for research purposes. The confocal probe imaging will not alter where and how the biopsies will be taken (no change to size of biopsy or location on cervix).
The procedure will add approximately 15 minutes to the duration of the standard outpatient procedure. During each examination, the anatomical location of all tissue areas in question will be recorded using the clock-position nomenclature system. Some normal areas will be also localized and recorded as control. Digital images will be recorded in the computer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Colposcopy Visit | Women with a scheduled colposcopy and biopsy appointment at the Women's Clinic at Vancouver General Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In Vivo Confocal Microscopy Probe | Device | Participants will have 2 areas on their cervical imaged by the confocal probe. |
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe | Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit |
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Inclusion Criteria:
Exclusion Criteria:
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Be scheduled for colposcopy & biopsy at the Vancouver General Hospital Women's Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Marette Lee, MD | BC Cancer Agency, Gynecologic Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| D065311 | Adenocarcinoma in Situ |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
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Cervical biopsies
| D009371 |
| Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |