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NCI UNC Project ESCC

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ClinicalTrials.gov Identifier: NCT03206125
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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 at Kamuzu Central 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 Design

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
Anticipated Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients
300 ESCC cases
Controls
300 controls


Outcome Measures

Primary Outcome Measures :
  1. esophageal squamous cell carcinoma [ Time Frame: At diagnosis ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
300 ESCC cases and 300 controls
Criteria
  • INCLUSION CRITERIA:
  • All suspected ESCC cases will be eligible for enrollment.
  • All KCH patients (Bullet)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.

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03206125


Contacts
Contact: Christian Abnet, Ph.D. (301) 594-1511 abnetc@mail.nih.gov

Locations
Malawi
Kazumu Central Hospital (KCH) Not yet recruiting
Lilongwe, Malawi
Contact: Christian Abnet, M.P.H.    (301) 594-1511    abnetc@mail.nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christian Abnet, Ph.D. National Cancer Institute (NCI)
More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03206125     History of Changes
Other Study ID Numbers: 999917120
17-C-N120
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: June 26, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Esophageal Squamous Cell Carcinoma
Case-Control Study
Risk Factors
Epidemiology

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases