Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA167421 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Jacobi Medical Center | OTHER |
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mLCI imaging | Experimental | mLCI device images cervical epithelium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mLCI Device | Device | imaging of cervical epithelium using mLCI device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Interferometric Data Acquired From Cervical Epithelium | measured by: ability to receive interferometric data from at least one portion of the cervical epithelium | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Automated Classification of Cervical Epithelium | The number of patients for which an interferometric tissue classification was made using optical mLCI data | day 1 |
| Number and Frequency of Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Wax, Ph.D. | professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | mLCI Imaging (Pilot) | Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. |
| FG001 | mLCI Imaging (Jacobi) | Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | mLCI Imaging (Pilot) | Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Interferometric Data Acquired From Cervical Epithelium | measured by: ability to receive interferometric data from at least one portion of the cervical epithelium | Posted | Number | patients | day 1 |
|
Day of study only
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mLCI Imaging (Pilot) | Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kengyeh Chu | Duke University | 919-681-2093 | ken.chu@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2017 | Oct 10, 2018 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of adverse events experienced by patients during the mLCI study.
| day 1 |
| BG001 |
| mLCI Imaging (Jacobi) |
Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Number of Patients With Automated Classification of Cervical Epithelium | The number of patients for which an interferometric tissue classification was made using optical mLCI data | Patients from whom epithelial interferometric data were successfully captured and for whom a corresponding colposcope image could be registered. No pilot study patients were included as no colposcopic examination was conducted in the pilot phase. | Posted | Number | patients | day 1 |
|
|
|
| Secondary | Number and Frequency of Adverse Events | Number of adverse events experienced by patients during the mLCI study. | Posted | Number | events | day 1 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | mLCI Imaging (Jacobi) | Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
Not provided