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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-GYN-97244 | Other Identifier | UT MD Anderson Cancer Center | |
| UTHSC-HSC-MS-04-307 | |||
| BCCA-RO2-1476 | |||
| CDR0000366944 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia.
PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.
OBJECTIVES:
OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.
NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence Spectroscopy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colposcopic biopsy | Procedure | Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescent Measurements of Cervix | Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site. | Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy. |
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Inclusion Criteria:
Exclusion Criteria:
1) Pregnant individuals will be ineligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Helen Rhodes, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States | ||
| British Columbia Cancer Agency - Vancouver Cancer Centre |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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| Light-Scattering Spectroscopy | Procedure | Spectroscopy readings taken in 2 regions of cervix. |
|
|
| Vancouver |
| British Columbia |
| V5Z 4E6 |
| Canada |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011230 | Precancerous Conditions |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013057 | Spectrum Analysis |
| D013050 | Spectrometry, Fluorescence |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
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