Cervical CancerPhase 2MDC_AlgoNCT01094132
Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection
A Phase 2 study testing Multispectral Digital Colposcope (MDC) in people with Cervical Cancer and Precancerous Condition, run by British Columbia Cancer Agency at 3 sites in 2 countries.
Trial summary
Precancerous lesions of the cervix occur frequently and are treatable. This justifies a population-based screening program. Following an abnormal Pap smear, patients are referred for a colposcopic exam to confirm the presence/stage of disease and select appropriate treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- What is being tested?
- Multispectral Digital Colposcope (MDC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 551 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2012to 9 Nov 2016
- 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
- Included subjects will be ≥18 years old.
- Included subjects will not be pregnant or breast feeding.
- Included subjects will have a negative urine pregnancy test.
- Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
- Included subjects will indicate understanding of the study.
- Included subjects will provide informed consent to participate.
Who cannot join
- Individuals <18 years old will be excluded.
- Pregnant and breast feeding individuals will be excluded.
- Individuals that have had an operation to remove their cervix will be excluded.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Brookdale Hospital and Medical Center
Brooklyn, New York, 11212
Texas Tech Health Sciences Center
El Paso, Texas, 79905
Canada1 site
Vancouver General Hospital - Women's Clinic (G&L Diamond Centre)
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.
Precancerous lesions of the cervix occur frequently and are treatable. This justifies a population-based screening program. Following an abnormal Pap smear, patients are referred for a colposcopic exam to confirm the presence/stage of disease and select appropriate treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give 'false positive' results (resulting in overtreatment). We are testing a device called a 'multispectral digital colposcope' to determine whether it is more effective at detecting precancerous cervical lesions than existing tools. Success in our study will make diagnoses more accurate and reduce the costs associated with unnecessary treatments.
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. 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 HPV swabbed. 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.
Study subjects may also be randomly asked to have additional pictures taken with another imaging device. a) The Fast Fluorescence Camera (FFC) is a modified digital camera that will capture images similar to that of the MDC. It will take a pair of images under two different lighting conditions - white light and violet light, both of which are used by the MDC. b) The Confocal Probe (CP) is a hand-held microscope used to collect images from the same location as the point probe. The cervix is topically stained with a fluorescent dye (Acriflavine) which is taken up by cell nuclei. The CP is then able to capture, in real time, images of the cells and their fluorescent nuclei.
This data will be used to train, test and valid 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. We will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.
- Conditions
- Cervical Cancer, Precancerous Condition
- Being tested
- Multispectral Digital Colposcope (MDC)
- Keywords
- cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, Nonmalignant Condition
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, 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 (MDC)Device
The MDC has 2 components: an optical probe \& a multispectral colposcope. The optical wand makes use of fluorescence \& reflectance spectroscopy; a light is shone on the cervix and the wand reports what it sees to a computer. Since cancer \& healthy cells interact differently with light, a computer can detect abnormalities. The multispectral colposcope is based on a conventional colposcope, which is already widely used. However, it is also able to produce fluorescence \& polarized reflectance images of the entire cervix. Computer analysis of these images can detect abnormalities on the cervix, defining their location and shape.
This trial involves combined analysis of MDC data. This may lead to more effective diagnosis of cervical abnormalities. The MDC will be used with standard care for patients presenting with cervical abnormalities (as detected by a Pap test). The MDC will not be used to guide patient management decisions.
All study subjects will receive this same intervention.
| Study group | Role | What they receive |
|---|---|---|
| Review by colposcopy + multispectral digital colposcopy | Other | All patients belong under this arm, as all will be reviewed by both conventional colposcopy and by Multispectral Digital Colposcopy (MDC). The nature of these techniques are explained below. Receives: Device: Multispectral Digital Colposcope (MDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope.
All study subjects will be evaluated for cervical abnormalities by 1) standard colposcopy and 2) the trial device (multispectral digital colposcope + wand). Results from each device will be compared, both in terms of the presence/absence of abnormalities and the stage/grade of abnormalities detected by both tools. Histopathological review for cervical abnormalities will be taken as the gold standard against which standard colposcopy and trial device results are measured.
Measured: Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startDec 2012
- Primary completion1 Sep 2016
- Study completion9 Nov 2016
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.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Texas Tech University Health Sciences Center, Brookdale University Hospital Medical Center, William Marsh Rice University, The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Michele Follen, MD, PhD, Principal investigator, Brookdale Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094132
- Sponsor's protocol ID
- BCCR-H09-03303
- Other IDs
- P01CA082710, H09-03303
- Acronym
- MDC_Algo
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2010
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.
- ClinicalTrials.gov ID
- NCT01094132
- Acronym / sponsor ID
- MDC_Algo / BCCR-H09-03303
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, Nonmalignant Condition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Texas Tech University Health Sciences Center, Brookdale University Hospital Medical Center, William Marsh Rice University, The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center
- Study start
- Dec 2012
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 26 Mar 2010 (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.
Precancerous lesions of the cervix occur frequently and are treatable. This justifies a population-based screening program. Following an abnormal Pap smear, patients are referred for a colposcopic exam to confirm the presence/stage of disease and select appropriate treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give 'false positive' results (resulting in overtreatment). We are testing a device called a 'multispectral digital colposcope' to determine whether it is more effective at detecting precancerous cervical lesions than existing tools. Success in our study will make diagnoses more accurate and reduce the costs associated with unnecessary treatments.
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. 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 HPV swabbed. 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.
Study subjects may also be randomly asked to have additional pictures taken with another imaging device. a) The Fast Fluorescence Camera (FFC) is a modified digital camera that will capture images similar to that of the MDC. It will take a pair of images under two different lighting conditions - white light and violet light, both of which are used by the MDC. b) The Confocal Probe (CP) is a hand-held microscope used to collect images from the same location as the point probe. The cervix is topically stained with a fluorescent dye (Acriflavine) which is taken up by cell nuclei. The CP is then able to capture, in real time, images of the cells and their fluorescent nuclei.
This data will be used to train, test and valid 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. We 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 |
|---|---|---|
| Review by colposcopy + multispectral digital colposcopy | Other | Device: Multispectral Digital Colposcope (MDC)All patients belong under this arm, as all will be reviewed by both conventional colposcopy and by Multispectral Digital Colposcopy (MDC). The nature of these techniques are explained below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Included subjects will be ≥18 years old.
- Included subjects will not be pregnant or breast feeding.
- Included subjects will have a negative urine pregnancy test.
- Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
- Included subjects will indicate understanding of the study.
Key exclusion criteria (3 listed)
- Individuals <18 years old will be excluded.
- Pregnant and breast feeding individuals will be excluded.
- Individuals that have had an operation to remove their cervix will be excluded.
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 (MDC)The MDC has 2 components: an optical probe \& a multispectral colposcope. The optical wand makes use of fluorescence \& reflectance spectroscopy; a light is shone on the cervix and the wand reports what it sees to a computer. Since cancer \& healthy cells interact differently with light, a computer can detect abnormalities. The multispectral colposcope is based on a conventional colposcope, which is already widely used. However, it is also able to produce fluorescence \& polarized reflectance images of the entire cervix. Computer analysis of these images can detect abnormalities on the cervix, defining their location and shape. This trial involves combined analysis of MDC data. This may lead to more effective diagnosis of cervical abnormalities. The MDC will be used with standard care for patients presenting with cervical abnormalities (as detected by a Pap test). The MDC will not be used to guide patient management decisions. All study subjects will receive this same intervention. | Device | Review by colposcopy + multispectral digital colposcopy |
Primary outcome
Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope.
Time frame: Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.
All study subjects will be evaluated for cervical abnormalities by 1) standard colposcopy and 2) the trial device (multispectral digital colposcope + wand). Results from each device will be compared, both in terms of the presence/absence of abnormalities and the stage/grade of abnormalities detected by both tools. Histopathological review for cervical abnormalities will be taken as the gold standard against which standard colposcopy and trial device results are measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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 Hospital and Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multispectral Digital Colposcope (MDC) in people with Cervical Cancer and Precancerous Condition, run by British Columbia Cancer Agency at 3 sites in 2 countries.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope. (time frame: Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.). 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 5 Jul 2019.