NCI UNC Project ESCC
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|ClinicalTrials.gov Identifier: NCT03206125|
Recruitment Status : Terminated (determined not to be human subjects research)
First Posted : July 2, 2017
Last Update Posted : May 20, 2020
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
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|
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 :||Observational|
|Actual Enrollment :||648 participants|
|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|
- Esophageal squamous cell carcinoma [ Time Frame: At diagnosis ]Pathology confirmed from endoscopic biopsy
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 ClinicalTrials.gov identifier (NCT number): NCT03206125
|Kazumu Central Hospital (KCH)|
|St Gabriel's Hospital|
|Principal Investigator:||Christian Abnet, Ph.D.||National Cancer Institute (NCI)|