Back to resultsThe Kilimanjaro Cervical Screening Project (KCCP)
Primary Purpose
Uterine Cervical Neoplasms, Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Cervical cancer screening
Sponsored by
About this trial
This is an interventional screening trial for Uterine Cervical Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Female
- Over 18 years of age
Exclusion Criteria:
- Previous removal of uterus
Sites / Locations
- Reproductive Health Centre, KCMC
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Cervical cancer screening
Arm Description
Outcomes
Primary Outcome Measures
Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras
Secondary Outcome Measures
Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs.
Full Information
NCT ID
NCT01968837
First Posted
September 30, 2013
Last Updated
April 12, 2016
Sponsor
Queen's University
Collaborators
Grand Challenges Canada, Kilimanjaro Christian Medical Centre, Tanzania
1. Study Identification
Unique Protocol Identification Number
NCT01968837
Brief Title
The Kilimanjaro Cervical Screening Project
Acronym
KCCP
Official Title
The Kilimanjaro Cervical Screening Project
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Grand Challenges Canada, Kilimanjaro Christian Medical Centre, Tanzania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Cervical Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1072 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical cancer screening
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cervical cancer screening
Primary Outcome Measure Information:
Title
Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Over 18 years of age
Exclusion Criteria:
Previous removal of uterus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Yeates, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Health Centre, KCMC
City
Moshi
Country
Tanzania
12. IPD Sharing Statement
Learn more about this trial
The Kilimanjaro Cervical Screening Project
We'll reach out to this number within 24 hrs