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Status unknownNCT02955667Updated Nov 4, 2016

The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer

An interventional study of invivo microscopy group and normal group in Cervical Cancer and Cervical Precancer, sponsored by Shanghai First Maternity and Infant Hospital. Status unknown. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-04.

Sponsored by Shanghai First Maternity and Infant Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
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Study 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, which makes it possible to diagnose cervical cancer without wounds.

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Conditions studied

  • Cervical Cancer
  • Cervical Precancer

Keywords

  • invivo microscopy
  • colposcopy
  • cervical precancer and cancer
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 600 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Shanghai First Maternity and Infant Hospital is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. cervical cytologic test result is HSIL
  2. persistent infection with high-risk HPV
  3. cervical pathological diagnosis is LSIL or HSIL

Exclusion criteria

Exclusion Criteria:

  1. acute infection of lower genital tract
  2. the wound in lower genital tract
  3. active bleeding in lower genital tract
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    invivo microscopy group

    patients receive invivo micro-colposcopy examination and do not have to receive the biopsies

    Procedure: invivo microscopy group

  • Other
    normal group

    patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

    Procedure: normal group

Interventions

  • Procedureinvivo microscopy group

    patients receive invivo micro-colposcopy examination

  • Procedurenormal group

    patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

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What researchers measure

Primary outcomes

  1. diagnostic accuracy rate

    Time frame: 1 day (time of the examination)

Secondary outcomes

  1. image accordance rate

    Time frame: 1 day (time of the examination)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02955667
Lead sponsor
Shanghai First Maternity and Infant Hospital
Responsible party
Sponsor
First posted
Nov 4, 2016
Start date
Dec 2016
Primary completion
Dec 2018 (estimated)
Last update
Nov 4, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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