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| ID | Type | Description | Link |
|---|---|---|---|
| 14037870 | Other Identifier | Institution of Medicine (IOM) | |
| NCI-2014-01790 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
If you agree to take part in this study, after you are in the operating room and under general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This probe will be applied to the cervix and images obtained. These images will be used for research. This should add about 10 minutes to the total time you are in the operating room.
There will be no change to the planned standard-of-care colposcopy and biopsy.
Follow-Up:
A member of the research team will call you within 30 days after the procedure to ask how you are feeling and if you are having any symptoms. This call should last about 5 minutes.
Length of Study:
Your active participation in this study will be over after the biopsy.
This is an investigational study. The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Resolution Microendoscopy (HRME) | Experimental | Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proflavine | Drug | 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization | Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging | AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Schmeler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Resolution Microendoscopy (HRME) | Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained. Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging. High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Resolution Microendoscopy (HRME) | Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained. Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging. High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization | Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study. | Due to not meeting enrollment requirements, data was not collected | Posted | 1 day |
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Serious adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent. Serious adverse events must be followed until clinical recovery is complete and laboratory tests have returned to baseline, progression of the event has stabilized, or there has been acceptable resolution of the event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Resolution Microendoscopy (HRME) | Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained. Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging. High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization. |
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Due to low accrual no analysis conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen M. Schmeler, MD | UT MD Anderson Cancer Center | 713-745-3518 | kschmele@mdanderson.org |
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| 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 | Jul 12, 2019 | Apr 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011370 | Proflavine |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D000609 | Aminoacridines |
| D000166 | Acridines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| High-Resolution Microendoscopy (HRME) Imaging | Procedure | in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization. |
|
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging | AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance. | Due to low accrual, no specimens were collected to be analyzed | Posted | 1 day |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| 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 |
| D011230 | Precancerous Conditions |
| D006571 | Heterocyclic Compounds |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |