NCT01968837

Brief Summary

Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,072

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

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

First Submitted

Initial submission to the registry

September 30, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

September 30, 2013

Last Update Submit

April 12, 2016

Conditions

Uterine Cervical NeoplasmsCervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras

    3 months

Secondary Outcomes (1)

  • Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs.

    3 months

Other Outcomes (1)

  • Measure accuracy, quality, and feasibility of SMS text messaging of cervical images obtained by smart phone in place of traditional transfer methods for digital cervical images.

    3 months

Study Arms (1)

Cervical cancer screening

NO INTERVENTION
Other: Cervical cancer screening

Interventions

Cervical cancer screeningOTHER
Cervical cancer screening

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Over 18 years of age

You may not qualify if:

  • Previous removal of uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Health Centre, KCMC

Moshi, Tanzania

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Karen Yeates, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Medicine

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 24, 2013

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

TA(1)