NCT02693379

Brief Summary

The purpose of this study is to determine whether smartphone photos may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with conventional VIA, for human papillomavirus (HPV) positive women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,041

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

July 8, 2015

Last Update Submit

February 22, 2016

Conditions

Cervical Precancer

Keywords

cervical cancerHPVVIAscreeningsmartphonetelemedicine

Outcome Measures

Primary Outcomes (1)

  • Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer

    Sensitivity and specificity will be calculated using histological results as gold-standard. All lesion Cin2 and worse will be considered as pathological.

    up to 12 months

Secondary Outcomes (1)

  • Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA.

    up to 12 months

Study Arms (1)

D-VIA

EXPERIMENTAL

HPV high risk-positive (16, 18, 45, 31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 68) women had a cervical examination using acetic acid (VIA) application and visual inspection.

Device: D-VIA

Interventions

D-VIADEVICE

D-VIA images were captured during the cervical examination with a smartphone. Biopsies and cytological samples were taken on all patients and analyzed for gold standard results. Images were shown to off site experts. D-VIA and VIA diagnoses were then compared. Women who were diagnosed on-site as pathological underwent appropriate treatment at the same consultation. Women who were diagnosed as pathological later by histopathological analyses were asked to return to the clinic for treatment.

D-VIA

Eligibility Criteria

Age30 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • HPV-positive
  • Attending the cervical cancer screening program conducted by the Saint-Damien Health-Care Centre
  • Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

You may not qualify if:

  • Previous Hysterectomy
  • Conditions that can interfere with visualization of the cervix
  • Pregnancy \> 20 weeks
  • Not able to comply with protocol study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Damien Health-Care Centre

Ambanja, Antsiranana, Madagascar

Location

Related Publications (2)

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PMID: 21351269BACKGROUND

  • Marquardt K. [Correlation of cervical cytology and histology]. Pathologe. 2011 Nov;32(6):491-6. doi: 10.1007/s00292-011-1479-2. German.

    PMID: 21822676BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Patrick Petignat, Professor

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2015

First Posted

February 26, 2016

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Data will be used for scientific publications and congress presentations.

Locations

MA(1)