Uterine Cervical NeoplasmsKCCPNCT01968837
The Kilimanjaro Cervical Screening Project
A study testing Cervical cancer screening in people with Uterine Cervical Neoplasms and Cervical Cancer, run by Queen's University at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms, Cervical Cancer
- What is being tested?
- Cervical cancer screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 1 siteTanzania
- Study dates
- May 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Over 18 years of age
Who cannot join
- Previous removal of uterus
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Uterine Cervical Neoplasms, Cervical Cancer
- Being tested
- Cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical cancer screeningOther
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer screening | No intervention | Not described Receives: Other: Cervical cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Principal investigator, Dr. Karen Yeates, Queen's University
- Investigators
- Karen Yeates, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968837
- Sponsor's protocol ID
- DMED-1545-12
- Acronym
- KCCP
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kilimanjaro Cervical Screening Project
- ClinicalTrials.gov ID
- NCT01968837
- Acronym / sponsor ID
- KCCP / DMED-1545-12
- Conditions
- Uterine Cervical Neoplasms, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer screening | No intervention | Other: Cervical cancer screening |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- Over 18 years of age
Key exclusion criteria (1 listed)
- Previous removal of uterus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical cancer screening | Other | Cervical cancer screening |
Primary outcome
Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras
Time frame: 3 months
1 secondary outcome
Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Yeates, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical cancer screening in people with Uterine Cervical Neoplasms and Cervical Cancer, run by Queen's University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.