Esophageal DysplasiaSTEPNCT01981876
Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital
An observational study of Esophageal Dysplasia, run by Tenwek Hospital at 1 site in Kenya.
Trial summary
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Dysplasia
- How many people
- 305 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2010to Dec 2014
- Phase
- Observational
- 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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Asymptomatic subjects residing within a 50 kilometer radius of Tenwek Hospital
Who may be able to join
- Age ≥ 20 years
- No dysphagia (subjects will be asked "do you have trouble swallowing food or water? Do they get stuck inside after you swallow?" in their primary language
Who cannot join
- Cardiac, respiratory, or metabolic disease that would increase the risk of endoscopy: history of myocardial infarction, arrhythmias, chronic obstructive pulmonary disease, diabetes, allergy to lidocaine.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.
Read the detailed description
The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology reports from unstained lesions and normal biopsies after staining with Lugol's iodine.
- Conditions
- Esophageal Dysplasia
- Keywords
- Dysplasia, Esophageal Squamous Cell Carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
Measured: 2 years
Secondary outcomes (3)
percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence
Measured: 2 years
percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence
Measured: 2 years
percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startOct 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DysplasiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenwek Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital, Mayo Clinic, AORTIC
- Responsible party
- Sponsor
- Investigators
- Michael M Mwachiro, MBChB, Principal investigator, Tenwek HospitalRuss E White, MD, Study chair, Tenwek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981876
- Sponsor's protocol ID
- P172/06/2010
- Acronym
- STEP
- Status last verified
- Feb 2015
- First submitted
- 29 Oct 2013
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital
- ClinicalTrials.gov ID
- NCT01981876
- Acronym / sponsor ID
- STEP / P172/06/2010
- Conditions
- Esophageal Dysplasia
- Keywords
- Dysplasia, Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Tenwek HospitalUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital, Mayo Clinic, AORTIC
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Nov 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.
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.
Detailed description
The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology reports from unstained lesions and normal biopsies after staining with Lugol's iodine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Asymptomatic subjects residing within a 50 kilometer radius of Tenwek Hospital
Key inclusion criteria (2 listed)
- Age ≥ 20 years
- No dysphagia (subjects will be asked "do you have trouble swallowing food or water? Do they get stuck inside after you swallow?" in their primary language
Key exclusion criteria (2 listed)
- Cardiac, respiratory, or metabolic disease that would increase the risk of endoscopy: history of myocardial infarction, arrhythmias, chronic obstructive pulmonary disease, diabetes, allergy to lidocaine.
- Unable or unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
Time frame: 2 years
3 secondary outcomes
percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence
Time frame: 2 years
percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence
Time frame: 2 years
percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence
Time frame: 2 years
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 27 Feb 2015.
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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.
Michael M Mwachiro, MBChB principal investigator
Tenwek Hospital
Russ E White, MD study chair
Tenwek Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Dysplasia, run by Tenwek Hospital at 1 site in Kenya.
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 2 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 27 Feb 2015. 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 Kenya. 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?
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence (time frame: 2 years). 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 27 Feb 2015.