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NCI UNC Project ESCC

A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03206125
Enrollment
648
Registered
2017-07-02
Start date
2017-08-01
Completion date
2020-05-15
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell Carcinoma, Case-Control Study, Risk Factors, Epidemiology

Brief summary

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....

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).

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Esophageal squamous cell carcinomaAt diagnosisPathology confirmed from endoscopic biopsy

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026