COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu


The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03206125
Recruitment Status : Terminated (determined not to be human subjects research)
First Posted : July 2, 2017
Last Update Posted : May 20, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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.


To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi because of the large number of cases in that country.


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


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


Food habits


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....

Condition or disease
Esophageal Squamous Cell Carcinoma

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 648 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

ESCC Cases
ESCC Cases

Primary Outcome Measures :
  1. Esophageal squamous cell carcinoma [ Time Frame: At diagnosis ]
    Pathology confirmed from endoscopic biopsy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
300 ESCC cases and 300 controls recruited from Kamuzu Central Hospital and St Gabriel s Hospital, Namitete (FWA: 00018517) which is 50 km from Kamuzu Central Hospital located in Lilongwe, Malawi.
  • 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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03206125

Layout table for location information
Kazumu Central Hospital (KCH)
Lilongwe, Malawi
St Gabriel's Hospital
Namitete, Malawi
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Christian Abnet, Ph.D. National Cancer Institute (NCI)
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT03206125    
Other Study ID Numbers: 999917120
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Esophageal Squamous Cell Carcinoma
Case-Control Study
Risk Factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases