The Kilimanjaro Cervical Screening Project | NCT01968837

Studies
The Kilimanjaro Cervical Screening Project

NCT01968837

Sponsor

Queen's University

Status

Completed

Last Update Posted

Apr 13, 2016Estimated

Enrollment

1,072Actual

Phase

Not Applicable

Conditions

Uterine Cervical Neoplasms
Cervical Cancer

Interventions

Cervical cancer screening

Countries

Tanzania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 30, 2013

First Submission Date that Met QC Criteria

Oct 18, 2013

First Posted Date

Oct 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2016

Last Update Posted Date

Apr 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Karen Yeates, Associate Professor, Department of Medicine, Queen's UniversityPrincipal Investigator

Lead Sponsor

Queen's UniversityOTHER

Collaborators

Name	Class
Grand Challenges Canada	OTHER
Kilimanjaro Christian Medical Centre, Tanzania	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,072Actual

Label	Type	Description	Intervention Names
Cervical cancer screening	No Intervention		Other: Cervical cancer screening

Name	Type	Description	Arm Group Labels	Other Names
Cervical cancer screening	Other		Cervical cancer screening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras		3 months

Secondary Outcomes

Measure	Description	Time Frame
Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs.		3 months

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Over 18 years of age

Exclusion Criteria:

Previous removal of uterus

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Yeates, MD	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Health Centre, KCMC		Moshi			Tanzania

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided