Cervical CancerNCT02955667
The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
A study testing invivo microscopy group and normal group in people with Cervical Cancer and Cervical Precancer, run by Shanghai First Maternity and Infant Hospital.
Trial summary
This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Cervical Precancer
- What is being tested?
- invivo microscopy group and normal group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cervical cytologic test result is HSIL
- persistent infection with high-risk HPV
- cervical pathological diagnosis is LSIL or HSIL
Who cannot join
- acute infection of lower genital tract
- the wound in lower genital tract
- active bleeding in lower genital tract
About this study
This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.
- Conditions
- Cervical Cancer, Cervical Precancer
- Being tested
- invivo microscopy group, normal group
- Keywords
- invivo microscopy, colposcopy, cervical precancer and cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invivo microscopy groupProcedure or surgery
patients receive invivo micro-colposcopy examination
normal groupProcedure or surgery
patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis
| Study group | Role | What they receive |
|---|---|---|
| invivo microscopy group | Experimental | patients receive invivo micro-colposcopy examination and do not have to receive the biopsies Receives: Procedure: invivo microscopy group |
| normal group | Other | patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis Receives: Procedure: normal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy rate
Measured: 1 day (time of the examination)
Secondary outcomes (1)
image accordance rate
Measured: 1 day (time of the examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955667
- Sponsor's protocol ID
- Fang Li
- Status last verified
- Oct 2016
- First submitted
- 29 Oct 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
- ClinicalTrials.gov ID
- NCT02955667
- Acronym / sponsor ID
- Fang Li
- Conditions
- Cervical Cancer, Cervical Precancer
- Keywords
- invivo microscopy, colposcopy, cervical precancer and cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 4 Nov 2016 (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.
This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| invivo microscopy group | Experimental | Procedure: invivo microscopy grouppatients receive invivo micro-colposcopy examination and do not have to receive the biopsies |
| normal group | Other | Procedure: normal grouppatients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cervical cytologic test result is HSIL
- persistent infection with high-risk HPV
- cervical pathological diagnosis is LSIL or HSIL
Key exclusion criteria (3 listed)
- acute infection of lower genital tract
- the wound in lower genital tract
- active bleeding in lower genital tract
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 |
|---|---|---|
| invivo microscopy grouppatients receive invivo micro-colposcopy examination | Procedure or surgery | invivo microscopy group |
| normal grouppatients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis | Procedure or surgery | normal group |
Primary outcome
diagnostic accuracy rate
Time frame: 1 day (time of the examination)
1 secondary outcome
image accordance rate
Time frame: 1 day (time of the examination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing invivo microscopy group and normal group in people with Cervical Cancer and Cervical Precancer, run by Shanghai First Maternity and Infant Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
diagnostic accuracy rate (time frame: 1 day (time of the examination)). 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 4 Nov 2016.