Carcinoma in Situ of Uterine CervixMDCwProbeNCT02406352
Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia
A study testing Multispectral Digital Colposcope with probe in people with Carcinoma in Situ of Uterine Cervix and Cervical Intraepithelial Neoplasias, run by Brookdale University Hospital Medical Center at 1 site in United States.
Trial summary
Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma in Situ of Uterine Cervix, Cervical Intraepithelial Neoplasias, High Grade Cervical Intraepithelial Neoplasia
- What is being tested?
- Multispectral Digital Colposcope with probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are at least 18 years old
- Are not pregnant (negative urine test) or breastfeeding
- Referred for colposcopy or LEEP treatment
- Can provide written informed consent
Who cannot join
- Women who do not meet the inclusion criteria
- Women who have had a hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Leonid Fradkin, PhD, 718-240-8225, lfradkin@bhmcny.org
Thelma Carrillo, MPH, 718-240-5978, tcarrill@bhmcny.org
About this study
Official title: Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.
Read the detailed description
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This version of the MDC incorporates an upgraded light source, and updates the firmware and the user interface. This results in shorter acquisition times and improved image and spectrum quality control. The MDC also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the MDC can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix.
Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV). After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the cervix using the point probe.
This data will be used to train, test and validate an algorithm specific to the MDC. The ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.
- Conditions
- Carcinoma in Situ of Uterine Cervix, Cervical Intraepithelial Neoplasias, High Grade Cervical Intraepithelial Neoplasia
- Being tested
- Multispectral Digital Colposcope with probe
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Digital Colposcope with probeDevice
Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study.
The standard of care for research participants will not change.
| Study group | Role | What they receive |
|---|---|---|
| Routine colposcopy and MDC with probe | Experimental | The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure. A control biopsy will also be obtained from patients who agree to provide it. The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope. Receives: Device: Multispectral Digital Colposcope with probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of precancerous cervical lesions or cervical cancer
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care.
Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied.
Measured: At point of care for colposcopy or treatment with LEEP (5 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma in Situ of Uterine CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brookdale University Hospital Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Follen, Brookdale University Hospital Medical Center
- Investigators
- Michele Follen, MD, PhD, Principal investigator, Brookdale University Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406352
- Sponsor's protocol ID
- 14-35
- Acronym
- MDCwProbe
- Status last verified
- Apr 2015
- First submitted
- 16 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT02406352
- Acronym / sponsor ID
- MDCwProbe / 14-35
- Conditions
- Carcinoma in Situ of Uterine Cervix, Cervical Intraepithelial Neoplasias, High Grade Cervical Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 618 participants (estimated)
- Lead sponsor
- Brookdale University Hospital Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.
Detailed description
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This version of the MDC incorporates an upgraded light source, and updates the firmware and the user interface. This results in shorter acquisition times and improved image and spectrum quality control. The MDC also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the MDC can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix.
Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV). After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the cervix using the point probe.
This data will be used to train, test and validate an algorithm specific to the MDC. The ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine colposcopy and MDC with probe | Experimental | Device: Multispectral Digital Colposcope with probeThe intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure. A control biopsy will also be obtained from patients who agree to provide it. The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who are at least 18 years old
- Are not pregnant (negative urine test) or breastfeeding
- Referred for colposcopy or LEEP treatment
- Can provide written informed consent
Key exclusion criteria (2 listed)
- Women who do not meet the inclusion criteria
- Women who have had a hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Digital Colposcope with probeCervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study. The standard of care for research participants will not change. | Device | Routine colposcopy and MDC with probe |
Primary outcome
Detection of precancerous cervical lesions or cervical cancer
Time frame: At point of care for colposcopy or treatment with LEEP (5 minutes).
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care. Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Follen, MD, PhD principal investigator
Brookdale University Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral Digital Colposcope with probe in people with Carcinoma in Situ of Uterine Cervix and Cervical Intraepithelial Neoplasias, run by Brookdale University Hospital Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonid Fradkin, PhD (718-240-8225, lfradkin@bhmcny.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of precancerous cervical lesions or cervical cancer (time frame: At point of care for colposcopy or treatment with LEEP (5 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.