- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206125
NCI UNC Project ESCC
A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
Background:
Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the world with high-risk. One of these is in East Africa and include the country of Malawi. Researchers want to learn what factors explain the high risk there so we can understand better what causes this cancer in people everywhere.
Objective:
To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi because of the large number of cases in that country.
Eligibility:
Adults at least 18 years old who have ESCC and live in a certain region of Malawi
Adults in the same age group and location who do not have ESCC
Design:
Participants will be screened at a hospital in Malawi.
Participants will have a 1-hour interview. They will answer questions about:
Demographics (age, ethnicity, education)
Place of residence
Medical history and family medical history
Drug, alcohol, and tobacco use
Hot beverage consumption
Indoor air pollution
Occupation
Food habits
Farming
Gastrointestinal health
Participants will have their teeth and fingernails examined.
Participants will be asked to give samples of blood, urine, saliva, toenails, and for the cancer cases, a small piece of their tumor.
Participants will have 4 phone calls a year for 2 years to ask about their health....
Study Overview
Status
Conditions
Detailed Description
Background: Esophageal cancer causes an estimated 400,000 deaths per year and ranks as the sixth leading cause of cancer death worldwide, just after breast cancer. Esophageal squamous cell carcinoma (ESCC) accounts for 89% of all esophageal cancer cases worldwide and many of the cases originate in two high risk regions, one in Asia and the other in Africa.
Smoking tobacco and heavy alcohol consumption do not explain the incidence rates in the high-risk regions. It is therefore important to consider a wide range of etiologic factors to explain the high rates of cancer in these populations.
Malawi has the highest incidence rates of ESCC in Africa. Our previous studies in Kenya and preliminary studies in Malawi point to a number of potential ESCC risk factors.
Objectives: Our study aims to enhance our understanding of the causes and outcomes for ESCC in Malawi
Eligibility: All suspected ESCC cases will be eligible for enrollment.
Design: We will conduct a case-control study of ESCC jointly at Kamuzu Central Hospital and St. Gabriel s Hospital, recruiting 300 ESCC cases and 300 controls, to (1) evaluate exposures (including consumption of very hot beverages, use of firewood as fuel, tooth loss and animal exposure) which may influence risk of ESCC in Malawi and (2) collect biological samples to quantify exposures of interest (included in the current proposal) and to study the genetics and genomics of ESCC tumors (to be included in a future proposal).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lilongwe, Malawi
- Kazumu Central Hospital (KCH)
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Namitete, Malawi
- St Gabriel's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- All suspected ESCC cases will be eligible for enrollment.
- All KCH and St Gabriel s patients greater than or eqaul to 18 years of age who are residents of the Central Region of Malawi and are diagnosed with histology-confirmed ESCC will be invited to participate as cases in the study.
EXCLUSION CRITERIA:
- Patients <18 years old
- Those living outside the Central Region, those who are medically unable to complete the study procedures (including questionnaire, biosample collection or endoscopy), and those who are unable to understand the study procedures or give informed consent.
While we do expect to see younger people with ESCC in Malawi (as we have seen in Kenya), cases under the age of 18 are rare: the field team would expect to see one or two a year. This estimate is in line with the cancer registry data from Malawi. Therefore, we will not enroll subjects younger than 18 years old.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Controls
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ESCC Cases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Esophageal squamous cell carcinoma
Time Frame: At diagnosis
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Pathology confirmed from endoscopic biopsy
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At diagnosis
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- White RE, Parker RK, Fitzwater JW, Kasepoi Z, Topazian M. Stents as sole therapy for oesophageal cancer: a prospective analysis of outcomes after placement. Lancet Oncol. 2009 Mar;10(3):240-6. doi: 10.1016/S1470-2045(09)70004-X. Epub 2009 Feb 18.
- Liu W, Snell JM, Jeck WR, Hoadley KA, Wilkerson MD, Parker JS, Patel N, Mlombe YB, Mulima G, Liomba NG, Wolf LL, Shores CG, Gopal S, Sharpless NE. Subtyping sub-Saharan esophageal squamous cell carcinoma by comprehensive molecular analysis. JCI Insight. 2016 Oct 6;1(16):e88755. doi: 10.1172/jci.insight.88755.
- Mlombe YB, Rosenberg NE, Wolf LL, Dzamalala CP, Chalulu K, Chisi J, Shaheen NJ, Hosseinipour MC, Shores CG. Environmental risk factors for oesophageal cancer in Malawi: A case-control study. Malawi Med J. 2015 Sep;27(3):88-92. doi: 10.4314/mmj.v27i3.3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- 999917120
- 17-C-N120
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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