NCT03160209|Completed
HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
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LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
Sponsor study identifier
observational
600
1 country
2
Study Start
July 26, 2017
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)The primary purpose of this single-center, case-control, non-interventional study is to determine risk factors which contribute to the development of esophageal squamous cell carcinoma (ESCC) at Kamuzu Central Hospital (KCH) and St. Gabriel Hospital (SGH) in Malawi.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
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.
May 4, 2017
Actual (reported)May 19, 2017
Actual (reported)July 26, 2017
Actual (reported)December 31, 2022
Actual (reported)December 31, 2022
Actual (reported)Risk factors for ESCC - HIV Infection
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: HIV infection, PAH exposure, Dietary factors including fumonisin and selenium, Scalding hot beverages and foods, Tobacco and alcohol consumption
2 years
Survival estimates after ESCC diagnosis in Malawi.
To assess survival after ESCC diagnosis in Malawi.
2 years
Risk factors for ESCC - HIV Infection
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: HIV infection
2 years
Risk factors for ESCC - PAH exposure
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: PAH exposure
2 years
Risk factors for ESCC - Dietary factors including fumonisin and selenium
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Dietary factors including fumonisin and selenium
The common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.
2 years
The germline genetic and epigenetic alterations associated with susceptibility to ESCC.
2 years
diagnosed with histologically confirmed ESCC
without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases
300 cases diagnosed with histologically confirmed ESCC and 300 patient controls without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases, 18 years, and older, male/female in Malawi.
UNC Project, Lighthouse Trust
Lilongwe, Malawi
UNC Project
Lilongwe, Malawi
Wu C, Hu Z, He Z, Jia W, Wang F, Zhou Y, Liu Z, Zhan Q, Liu Y, Yu D, Zhai K, Chang J, Qiao Y, Jin G, Liu Z, Shen Y, Guo C, Fu J, Miao X, Tan W, Shen H, Ke Y, Zeng Y, Wu T, Lin D. Genome-wide association study identifies three new susceptibility loci for esophageal squamous-cell carcinoma in Chinese populations. Nat Genet. 2011 Jun 5;43(7):679-84. doi: 10.1038/ng.849.
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
Satish Gopal, MD, MPH
UNC-CH
600 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2017
First Posted
May 19, 2017
Study Start
July 26, 2017
Actual (reported)Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma
2 years
Risk factors for ESCC - Scalding hot beverages and foods,
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Scalding hot beverages and foods
2 years
Risk factors for ESCC - Tobacco and alcohol consumption
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Tobacco and alcohol consumption
2 years
Contact the study team to confirm eligibility.
Metzger R, Schneider PM, Warnecke-Eberz U, Brabender J, Holscher AH. Molecular biology of esophageal cancer. Onkologie. 2004 Apr;27(2):200-6. doi: 10.1159/000076913.
Dlamini Z, Bhoola K. Esophageal cancer in African blacks of Kwazulu Natal, South Africa: an epidemiological brief. Ethn Dis. 2005 Autumn;15(4):786-9.
Mlombe Y, Dzamalala C, Chisi J, Othieno-Abinya N. Oesophageal cancer and Kaposi's sarcoma in Malawi: a comparative analysis. Malawi Med J. 2009 Jun;21(2):66-8. doi: 10.4314/mmj.v21i2.44562.
Msyamboza KP, Dzamalala C, Mdokwe C, Kamiza S, Lemerani M, Dzowela T, Kathyola D. Burden of cancer in Malawi; common types, incidence and trends: national population-based cancer registry. BMC Res Notes. 2012 Mar 16;5:149. doi: 10.1186/1756-0500-5-149.
Munishi MO, Hanisch R, Mapunda O, Ndyetabura T, Ndaro A, Schuz J, Kibiki G, McCormack V. Africa's oesophageal cancer corridor: Do hot beverages contribute? Cancer Causes Control. 2015 Oct;26(10):1477-86. doi: 10.1007/s10552-015-0646-9. Epub 2015 Aug 6.
Kayamba V, Bateman AC, Asombang AW, Shibemba A, Zyambo K, Banda T, Soko R, Kelly P. HIV infection and domestic smoke exposure, but not human papillomavirus, are risk factors for esophageal squamous cell carcinoma in Zambia: a case-control study. Cancer Med. 2015 Apr;4(4):588-95. doi: 10.1002/cam4.434. Epub 2015 Jan 30.
Chen J, Zhang N, Wakai T, Wei L, He Y, Kumagai N, Kitsu K, Wang S, Akazawa K. Effect of the interaction between the amount and duration of alcohol consumption and tobacco smoking on the risk of esophageal cancer: A case-control study. Exp Ther Med. 2010 Nov;1(6):991-997. doi: 10.3892/etm.2010.152. Epub 2010 Sep 29.
Wang JB, Fan JH, Liang H, Li J, Xiao HJ, Wei WQ, Dawsey SM, Qiao YL, Boffetta P. Attributable causes of esophageal cancer incidence and mortality in China. PLoS One. 2012;7(8):e42281. doi: 10.1371/journal.pone.0042281. Epub 2012 Aug 2.
Kumagai N, Wakai T, Akazawa K, Ling Y, Wang S, Shan B, Okuhara Y, Hatakeyama Y, Kataoka H. Heavy alcohol intake is a risk factor for esophageal squamous cell carcinoma among middle-aged men: A case-control and simulation study. Mol Clin Oncol. 2013 Sep;1(5):811-816. doi: 10.3892/mco.2013.142. Epub 2013 Jul 4.
Jessri M, Rashidkhani B, Hajizadeh B, Jessri M, Gotay C. Macronutrients, vitamins and minerals intake and risk of esophageal squamous cell carcinoma: a case-control study in Iran. Nutr J. 2011 Dec 20;10:137. doi: 10.1186/1475-2891-10-137.
Chen Y, Tong Y, Yang C, Gan Y, Sun H, Bi H, Cao S, Yin X, Lu Z. Consumption of hot beverages and foods and the risk of esophageal cancer: a meta-analysis of observational studies. BMC Cancer. 2015 Jun 2;15:449. doi: 10.1186/s12885-015-1185-1.
Sun G, Wang S, Hu X, Su J, Huang T, Yu J, Tang L, Gao W, Wang JS. Fumonisin B1 contamination of home-grown corn in high-risk areas for esophageal and liver cancer in China. Food Addit Contam. 2007 Feb;24(2):181-5. doi: 10.1080/02652030601013471.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
January 6, 2023
Record last verified: 2023-01
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