AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaNCT00901173

A Pilot for a Case-Control Study of Esophageal Squamous Cell Carcinoma in Western Kenya

An observational study of Esophageal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Esophageal cancer is the sixth leading cause of cancer deaths worldwide. Two primary cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Of the two, esophageal squamous cell carcinoma (ESCC) accounts for more than 80 percent of all deaths from esophageal cancer. Read more about this study

Who is it for?
Ages 7 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Esophageal Squamous Cell Carcinoma
How many people
372 participants
Where
1 siteKenya
Study dates
10 Feb 2014to 20 Apr 2020
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 7 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: ESCC patients and controls that live within 50 km of Tenwek Hospital

Who may be able to join

  • Consent to participate in the study
  • Pathologically diagnosed with esophageal squamous cell carcinoma at Tenwek Hospital, Bomet Kenya
  • Primary residence within 50 kilometers of Tenwek Hospital, Bomet Kenya
  • Consent to participation in the study
  • No previous history of malignancy
  • Primary residence within 50 kilometers of Tenwek Hospital, Bomet Kenya

Who cannot join

  • Does not consent to participation in the study
  • Mental impairment that precludes consenting to or completing the study questionnaire
  • Controls:
  • Does not consent to participation in the study
  • Mental impairment that precludes consenting to or completing the study questionnaire

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Tenwek Hospital

    Bornet

Other trials in Kenya

About this study

Official title: The THINKER Study: A Pilot for a Case-Control of Esophageal Squamous Cell Carcinoma in Western Kenya

Background:

  • Esophageal cancer is the sixth leading cause of cancer deaths worldwide. Two primary cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Of the two, esophageal squamous cell carcinoma (ESCC) accounts for more than 80 percent of all deaths from esophageal cancer. Many cases occur in certain areas with defined geographic boundaries, including parts of Kenya.
  • Studies of ESCC in developed countries (such as the United States) suggest that heavy tobacco and alcohol use, poor diet, and low socioeconomic status are the primary risk factors. Males and African Americans are also at higher risk. However, these risk factors do not fully explain the prevalence of cases in several of the identified geographic areas.
  • ESCC is the most common cancer seen at Tenwek Hospital in western Kenya, and a notable number of patients are 30 years of age or younger.
Read more

Objectives:

  • To test the feasibility of a new protocol by recruiting visitors to Tenwek Hospital and volunteers from the general population for study purposes.
  • To use the new protocol to obtain blood and urine samples from ESCC cases in Tenwek Hospital and from nonpatient volunteers.

Eligibility:

  • Hospital patients and volunteers who live within 50 kilometers of Tenwek Hospital in western Kenya.

Design:

  • All participants will complete a questionnaire and provide blood and urine samples for testing.
  • The questionnaire will include questions about individual and family medical history, living conditions, lifestyle, habits, and diet.
  • Blood and urine samples will be collected from all participants after the questionnaire.
  • Biological samples will be shipped to the United States for further testing.
  • Treatment will not be offered as part of this study.
Read the detailed description

This pilot study will assess the feasibility of completing the first formal case-control study to examine etiologic factors for esophageal squamous cell carcinoma (ESCC) in Kenya and will be conducted in Western Kenya, a high-risk area for ESCC.

Esophageal cancer causes over 380,000 deaths per year and ranks as the sixth leading cause of cancer death worldwide. Two primary cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Although the rates of esophageal adenocarcinoma have risen rapidly in the United States and elsewhere, ESCC still accounts for 80% of all esophageal cancer cases in the world. Many of these cases occur in high-risk areas with sharp geographic boundaries within China, Iran, a small region of South America, South Africa, and Kenya. Studies of ESSC in economically developed countries, such as the US, point to smoking tobacco, heavy alcohol drinking, poor diets deficient in fresh fruits and vegetables, and low socioeconomic status as the main etiologic factors. Other independent risk factors may include being male and being African-American. Smoking tobacco and heavy alcohol consumption do not explain the incidence rates in the high-risk regions because these habits are less common and less intensely practiced in these high-risk areas compared to the low risk area. Also, in highrisk areas the incidence rates are similar in men and women despite differences in the rates of tobacco smoking and alcohol drinking. Therefore, it is important to consider a wide range of etiologic factors to explain the high rates of cancer in these populations.

Tenwek Hospital is a 300 bed mission hospital located in Bomet District, Rift Valley Province, approximately 200 miles from Nairobi in the west of Kenya. Tenwek serves as a primary health care facility for approximately 400,000 people, and it has become a referral center for a broader population. ESCC is the most common malignancy seen at Tenwek Hospital and the patients show a very unusual age distribution with 10% of cases less than or equal to 30 years of age.

We will conduct a pilot for a case-control study of ESCC at Tenwek Hospital, recruiting people that live within 50 km of the hospital. Initial pilot testing showed that neither hospital-visitor controls nor general-population controls were practical control sources. We now plan to test the feasibility of collecting 50 hospital-based non-cancer patient controls. We will then enroll 50 cases and 50 additional hospital-based non-cancer patient controls to test all aspects of our protocol. We will ship the biological samples collected from these individuals to the US and test their suitability for our intended assays. All subjects will be interviewed using a structured questionnaire and will be asked to provide biological samples including blood and urine. Environmental risk factors (including lifestyle, habits, and diet) will be assessed through questionnaires.

Keywords
Case-Control Study, Esophageal Squamous Cell Carcinoma, Risk Factors
Medical subject headings
Esophageal Squamous Cell Carcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Esophageal squamous cell carcinoma

    determined by pathology results from endoscopic biopsy

    Measured: At diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2009 (estimated)
  2. Study start10 Feb 2014
  3. Primary completion20 Apr 2020
  4. Study completion20 Apr 2020

Resources

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
Case-control
Time perspective
Prospective
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00901173
Sponsor's protocol ID
999909141
Other IDs
09-C-N141
Status last verified
Apr 2020
First submitted
12 May 2009
Last updated
24 Apr 2020
Results posted
No

Publications

  • Dawsey SP, Tonui S, Parker RK, Fitzwater JW, Dawsey SM, White RE, Abnet CC. Esophageal cancer in young people: a case series of 109 cases and review of the literature. PLoS One. 2010 Nov 22;5(11):e14080. doi: 10.1371/journal.pone.0014080.

    PubMed 21124934

  • White RE, Abnet CC, Mungatana CK, Dawsey SM. Oesophageal cancer: a common malignancy in young people of Bomet District, Kenya. Lancet. 2002 Aug 10;360(9331):462-3. doi: 10.1016/S0140-6736(02)09639-3.

    PubMed 12241722

  • Nieminen MT, Novak-Frazer L, Collins R, Dawsey SP, Dawsey SM, Abnet CC, White RE, Freedman ND, Mwachiro M, Bowyer P, Salaspuro M, Rautemaa R. Alcohol and acetaldehyde in African fermented milk mursik--a possible etiologic factor for high incidence of esophageal cancer in western Kenya. Cancer Epidemiol Biomarkers Prev. 2013 Jan;22(1):69-75. doi: 10.1158/1055-9965.EPI-12-0908. Epub 2012 Nov 15.

    PubMed 23155139

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) 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 6 inclusion and 5 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 24 Apr 2020. 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?

Esophageal squamous cell carcinoma (time frame: At diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00901173, which also lists 3 linked publications.

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 24 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in