Precancerous ConditionConfocalNCT02574442
Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer
An observational study of Precancerous Condition and Cervical Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Precancerous Condition, Cervical Cancer
- What is being tested?
- In Vivo Confocal Microscopy Probe
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 1 Jun 2020
- Phase
- Observational
- 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
Study population: Be scheduled for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic
Who may be able to join
- indicate understanding of the study
- provide informed consent to participate
- 18 years old or older
- not pregnant and have negative urine pregnancy test
- be schedule for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic
Who cannot join
- they are breast-feeding
- they had an operation to remove their cervix
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Hand-held In Vivo Confocal Microscopy Probe for Detection of Cervical Intraepithelial Neoplasia
The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. The confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.
Read the detailed description
All subjects will undergo standard management (colposcopy) for their cervical lesion as scheduled. For cervical sites suspicious of dysplasia, acriflavine hydrochloride 0.05% solution will be applied topically, then rinsed with saline prior to in vivo confocal imaging with the hand-held probe. Following that, a biopsy of the suspicious site will be performed irrespective of the confocal microscopy finding. A biopsy of the normal site will be taken for research purposes. The confocal probe imaging will not alter where and how the biopsies will be taken (no change to size of biopsy or location on cervix).
The procedure will add approximately 15 minutes to the duration of the standard outpatient procedure. During each examination, the anatomical location of all tissue areas in question will be recorded using the clock-position nomenclature system. Some normal areas will be also localized and recorded as control. Digital images will be recorded in the computer.
- Conditions
- Precancerous Condition, Cervical Cancer
- Being tested
- In Vivo Confocal Microscopy Probe
- Keywords
- cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ
- Medical subject headings
- Precancerous Conditions, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Adenocarcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vivo Confocal Microscopy ProbeDevice
Participants will have 2 areas on their cervical imaged by the confocal probe.
| Study group | Role | What they receive |
|---|---|---|
| Initial Colposcopy Visit | Women with a scheduled colposcopy and biopsy appointment at the Women's Clinic at Vancouver General Hospital Receives: Device: In Vivo Confocal Microscopy Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe
Measured: Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Sep 2019
- Primary completion31 Dec 2019
- Study completion1 Jun 2020
Why it stopped: Funding has run out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous ConditionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marette Lee, MD, Principal investigator, BC Cancer Agency, Gynecologic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574442
- Sponsor's protocol ID
- BCCR - H15-01726
- Other IDs
- P01CA082710, H15-01726
- Acronym
- Confocal
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2015
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Hand-held In Vivo Confocal Microscopy Probe for Detection of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT02574442
- Acronym / sponsor ID
- Confocal / BCCR - H15-01726
- Conditions
- Precancerous Condition, Cervical Cancer
- Keywords
- cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding has run out
- Enrolment
- 60 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 12 Oct 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.
The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. The confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.
Detailed description
All subjects will undergo standard management (colposcopy) for their cervical lesion as scheduled. For cervical sites suspicious of dysplasia, acriflavine hydrochloride 0.05% solution will be applied topically, then rinsed with saline prior to in vivo confocal imaging with the hand-held probe. Following that, a biopsy of the suspicious site will be performed irrespective of the confocal microscopy finding. A biopsy of the normal site will be taken for research purposes. The confocal probe imaging will not alter where and how the biopsies will be taken (no change to size of biopsy or location on cervix).
The procedure will add approximately 15 minutes to the duration of the standard outpatient procedure. During each examination, the anatomical location of all tissue areas in question will be recorded using the clock-position nomenclature system. Some normal areas will be also localized and recorded as control. Digital images will be recorded in the computer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Initial Colposcopy Visit | – | Device: In Vivo Confocal Microscopy ProbeWomen with a scheduled colposcopy and biopsy appointment at the Women's Clinic at Vancouver General Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Be scheduled for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic
Key inclusion criteria (5 listed)
- indicate understanding of the study
- provide informed consent to participate
- 18 years old or older
- not pregnant and have negative urine pregnancy test
- be schedule for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic
Key exclusion criteria (2 listed)
- they are breast-feeding
- they had an operation to remove their cervix
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 |
|---|---|---|
| In Vivo Confocal Microscopy ProbeParticipants will have 2 areas on their cervical imaged by the confocal probe. | Device | Initial Colposcopy Visit |
Primary outcome
Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe
Time frame: Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit
Results and safety
The study was stopped early (reason given: Funding has run out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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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.
Marette Lee, MD principal investigator
BC Cancer Agency, Gynecologic Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precancerous Condition and Cervical Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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 5 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: stopped early, as of the sponsor's last update on 18 Mar 2024. 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 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.
Are results available for this study?
The study was stopped early (reason given: Funding has run out). Results are not available in the source record.
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 pre-cancer abnormalities of the cervix by the confocal microscopy probe (time frame: Probe measurements on participant's cervix should take no more than 10 minutes during the clinical 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 18 Mar 2024.