NCT03206125|Terminated
Study Stopped
determined not to be human subjects research
NCI UNC Project ESCC
A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
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determined not to be human subjects research
A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
Sponsor study identifier
Secondary identifiers
observational
648
1 country
2
Study Start
August 1, 2017
Actual (reported)Primary Completion
May 15, 2020
Actual (reported)Study Completion
May 15, 2020
Actual (reported)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....
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2017
Actual (reported)July 2, 2017
Actual (reported)August 1, 2017
Actual (reported)May 15, 2020
Actual (reported)May 15, 2020
Actual (reported)Esophageal squamous cell carcinoma
Pathology confirmed from endoscopic biopsy
At diagnosis
Controls
ESCC Cases
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.
Kazumu Central Hospital (KCH)
Lilongwe, Malawi
St Gabriel's Hospital
Namitete, Malawi
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.
Christian Abnet, Ph.D.
National Cancer Institute (NCI)
648 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2017
First Posted
July 2, 2017
Study Start
August 1, 2017
Actual (reported)Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma
Contact the study team to confirm eligibility.
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.
Primary Completion
May 15, 2020
Actual (reported)Study Completion
May 15, 2020
Actual (reported)Last Updated
May 20, 2020
Record last verified: 2020-05
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