Cervical CancerPhase 2FFCNCT02406365
Diagnostic Imaging Aid for Management of Cervical Lesions
A Phase 2 study testing Diagnostic imaging aid for one-visit management of cervical lesions in people with Cervical Cancer and Cervical Intraepithelial Neoplasias, run by Brookdale University Hospital Medical Center at 1 site in United States.
Trial summary
A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy
- What is being tested?
- Diagnostic imaging aid for one-visit management of cervical lesions
- 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
- Apr 2015to Dec 2017
- Phase
- Phase 2
- 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
- Women who are not pregnant as confirmed by a urine test
- Women who are not breastfeeding
- Women who understand the study procedures and 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
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 Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy, Precancerous Cervical Lesions
- Being tested
- Diagnostic imaging aid for one-visit management of cervical lesions
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging aid for one-visit management of cervical lesionsDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard of care plus imaging with research devices | Experimental | Eligible patients who consent to participate in the research study will receive their standard of care colposcopy or treatment with the Loop Electrosurgical Excision Procedure (LEEP). Additionally, cervical images will be taken using the diagnostic imaging aid. The cervical images will be compared to the histopathology from the biopsies taken as part of the patients' standard of care for colposcopy. If the patient is presenting for the LEEP procedure, then she will be asked if one or two biopsies can be obtained prior to the procedure but after anesthesia has been administered.
The imaging device is not being used to make a diagnosis, but rather to develop an algorithm to make more efficacious and timely diagnoses of cervical neoplasias in the future. Receives: Device: Diagnostic imaging aid for one-visit management of cervical lesions |
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 handheld imaging research device will also be used to capture cervical images. The images will be analyzed and compared to the biopsies obtained. The imaging device will not be used to make a diagnosis. As part of the research study, one or two additional biopsies will be obtained if the patient agrees. These additional biopsies will serve as the control tissue, since they will be taken from tissue that appears normal through the colposcope.
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 startApr 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 Cervical CancerStudies 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 2
- 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, PhD, Principal investigator, Brookdale University Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406365
- Sponsor's protocol ID
- 14-36
- Acronym
- FFC
- Status last verified
- Apr 2015
- First submitted
- 17 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 Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
- ClinicalTrials.gov ID
- NCT02406365
- Acronym / sponsor ID
- FFC / 14-36
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy, Precancerous Cervical Lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 618 participants (estimated)
- Lead sponsor
- Brookdale University Hospital Medical CenterUniversity, hospital or other
- Study start
- Apr 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.
A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus imaging with research devices | Experimental | Device: Diagnostic imaging aid for one-visit management of cervical lesionsEligible patients who consent to participate in the research study will receive their standard of care colposcopy or treatment with the Loop Electrosurgical Excision Procedure (LEEP). Additionally, cervical images will be taken using the diagnostic imaging aid. The cervical images will be compared to the histopathology from the biopsies taken as part of the patients' standard of care for colposcopy. If the patient is presenting for the LEEP procedure, then she will be asked if one or two biopsies can be obtained prior to the procedure but after anesthesia has been administered. The imaging device is not being used to make a diagnosis, but rather to develop an algorithm to make more efficacious and timely diagnoses of cervical neoplasias in the future. |
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
- Women who are not pregnant as confirmed by a urine test
- Women who are not breastfeeding
- Women who understand the study procedures and 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 |
|---|---|---|
| Diagnostic imaging aid for one-visit management of cervical lesions | Device | Standard of care plus imaging with research devices |
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 handheld imaging research device will also be used to capture cervical images. The images will be analyzed and compared to the biopsies obtained. The imaging device will not be used to make a diagnosis. As part of the research study, one or two additional biopsies will be obtained if the patient agrees. These additional biopsies will serve as the control tissue, since they will be taken from tissue that appears normal through the colposcope.
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, 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 Phase 2 study testing Diagnostic imaging aid for one-visit management of cervical lesions in people with Cervical Cancer 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.