Esophageal Squamous Cell CarcinomaNCT03160209
HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
An observational study of Esophageal Squamous Cell Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in Malawi.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 600 participants
- Where
- 2 sitesMalawi
- Study dates
- 26 Jul 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Cases Inclusion Criteria
- All patients > 18 years of age diagnosed with histologically confirmed ESCC are eligible to be a case regardless of sex or place of residence.
- Diagnosis of ESCC (histologically confirmed)
- Subject able to understand and provide written consent in English or Chichewa
- Able to understand and comply with study procedures for the entire length of the study
- Controls Inclusion Criteria
Show all 9Show fewer
- All patients > 18 years of age without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases are eligible to be controls, regardless of age, sex, or place of residence
- Subject able to understand and provide written consent in English or Chichewa
- Able to understand and comply with study procedures for the entire length of the study
Who cannot join
- Cases Exclusion Criteria
- Healthcare provider determines it is unsafe to perform a biopsy
- Mental impairment which precludes provision of informed consent
- Patients who are unable to provide their past medical history
- Controls Exclusion Criteria
- All patients > 18 years of age with a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases are ineligible to be controls
Show all 9Show fewer
- Patients with significant difficulty swallowing
- Mental impairment which precludes provision of informed consent
- Patients who are unable to provide their past medical history
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
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.
Read the detailed description
RATIONALE FOR RESEARCH
The Rift Valley of Africa is a 'hot spot' for ESCC, yet little is known about the etiology of this disease in Sub-Saharan Africa. In Malawi, ESCC is the third commonest cancer nationwide behind Kaposi sarcoma and cervical carcinoma. Among cancers that are not classically HIV-related, ESCC has the highest incidence in Malawi. The ESCC burden recorded in the national cancer registry is also likely an underestimate, as many cases may go undiagnosed and unregistered. Additionally, few data are available on the epidemiology of ESCC in Malawi, and underlying reasons for high frequency of the disease are largely unknown. This knowledge gap is a major barrier to public health prevention efforts. Given that survival after ESCC diagnosis is dismal in Malawi (12% at 1 year), developing evidence-based prevention efforts is paramount.
The proposed study will make a significant contribution to existing literature from Malawi and Sub-Saharan Africa in several important respects. First, previous epidemiologic studies of ESCC in Malawi have been limited by challenges with appropriate control selection, which may have limited the validity of their findings. Secondly, our study will include prospective clinical follow-up of confirmed ESCC cases as they receive treatment under local conditions to provide accurate survival estimates. Thirdly, biospecimens from consenting patients will permit etiology and pathogenesis studies to understand mechanisms of ESCC development, which can be correlated with high-quality clinical and epidemiologic data. Finally, we plan to coordinate with other ESCC researchers in eastern and southern Africa to harmonize data collection, and help create a regional consortium in which Malawi can be a founding member and active participant.
Primary Objective: Identify demographic and environmental risk factors for ESCC through a case-control study implemented at KCH and SGH. Hypothesis: Modifiable risk factors contribute significantly to ESCC. These include polycyclic aromatic hydrocarbon (PAH) exposure from various sources, excessively hot beverages, dietary factors such as maize fumonisin and low selenium, and HIV infection.
Secondary Objective: Identify common genetic and epigenetic alterations in germline and somatic DNA associated with ESCC development. Hypothesis: Recurring genetic and epigenetic alterations can facilitate risk stratification, development of early detection biomarkers, and identification of novel treatment strategies.
Procedures
After informed consent and study enrollment, subjects will be interviewed using a structured questionnaire and provide biological samples including saliva, blood, urine, and toenail clippings. Esophageal biopsies will be taken for diagnostic confirmation and to support molecular studies. If patients suspected to have ESCC are enrolled but then pathologically confirmed to have an alternate diagnosis, they will be withdrawn. HIV testing will be offered to all participants, and CD4, HIV RNA, and ART status documented for HIV-infected participants. Exposures will be measured using the questionnaire and laboratory analyses of saliva, blood, urine, and toenail samples. We will collect information on: demographic characteristics; HIV status; tobacco and drug use; alcohol consumption; medical history; family history of cancer; indoor air pollution; occupational history; diet, cooking, and food preservation; beverage history including temperature; farming; signs and symptoms of upper gastrointestinal disease; oral health; anthropometric indices; and reproductive history. To examine correlates with patient outcomes, telephone follow-up to assess vital status will be done every 3 months until 2 years from enrollment. Biological samples will be stored in freezers and transferred to the US only for assays that are currently unavailable in Malawi. Laboratory testing will include serum selenium level, blood and urine testing for PAH exposure, tumor immunohistochemistry assays, salivary DNA isolation for genetic studies, and molecular profiling of ESCC tumors.
Analysis
Sample size will include 300 ESCC cases and 300 controls; 66-68 case control pairs will be enrolled per year, over 3 years, assuming a response rate of 75% in the endoscopy clinic. With 300 case-control pairs, estimated statistical power for an exposure with control population prevalence of 10% and OR 2.0 is 81%, using alpha level 0.05, with higher power for higher control exposure rates and odds ratios. Expected prevalence for key exposures (tobacco and alcohol, hot tea, PAH exposure, selenium deficiency, HIV) is 10-50% in the control population. To assess epidemiologic risk factors for ESCC, we will use logistic regression to estimate odds ratios and 95% confidence intervals for each exposure, while controlling for possible confounders. Survival estimates will be generated using Kaplan-Meyer curves to estimate overall survival at 6, 12 and 24 months.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- risk factors, case-control study
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 300 esophageal cases | diagnosed with histologically confirmed ESCC | |
| 300 patient controls | without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Survival estimates after ESCC diagnosis in Malawi.
To assess survival after ESCC diagnosis in Malawi.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (2)
The common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.
To identify and characterize common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.
Measured: 2 years
The germline genetic and epigenetic alterations associated with susceptibility to ESCC.
To identify and characterize germline genetic and epigenetic alterations associated with susceptibility to ESCC.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start26 Jul 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satish Gopal, MD, MPH, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160209
- Sponsor's protocol ID
- LCCC 1608
- Status last verified
- Jan 2023
- First submitted
- 4 May 2017
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21642993Parkin 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.
PubMed 15761078Metzger 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.
PubMed 15138356Dlamini Z, Bhoola K. Esophageal cancer in African blacks of Kwazulu Natal, South Africa: an epidemiological brief. Ethn Dis. 2005 Autumn;15(4):786-9.
PubMed 16259509Mlombe 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.
PubMed 20345007Msyamboza 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.
PubMed 22424105Munishi 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.
PubMed 26245249Kayamba 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.
PubMed 25641622Chen 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.
PubMed 22993631Wang 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.
PubMed 22876312Kumagai 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.
PubMed 24649251Jessri 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.
PubMed 22185224Chen 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.
PubMed 26031666Sun 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.
PubMed 17364919
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
- ClinicalTrials.gov ID
- NCT03160209
- Acronym / sponsor ID
- LCCC 1608
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- risk factors, case-control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONALE FOR RESEARCH
The Rift Valley of Africa is a 'hot spot' for ESCC, yet little is known about the etiology of this disease in Sub-Saharan Africa. In Malawi, ESCC is the third commonest cancer nationwide behind Kaposi sarcoma and cervical carcinoma. Among cancers that are not classically HIV-related, ESCC has the highest incidence in Malawi. The ESCC burden recorded in the national cancer registry is also likely an underestimate, as many cases may go undiagnosed and unregistered. Additionally, few data are available on the epidemiology of ESCC in Malawi, and underlying reasons for high frequency of the disease are largely unknown. This knowledge gap is a major barrier to public health prevention efforts. Given that survival after ESCC diagnosis is dismal in Malawi (12% at 1 year), developing evidence-based prevention efforts is paramount.
The proposed study will make a significant contribution to existing literature from Malawi and Sub-Saharan Africa in several important respects. First, previous epidemiologic studies of ESCC in Malawi have been limited by challenges with appropriate control selection, which may have limited the validity of their findings. Secondly, our study will include prospective clinical follow-up of confirmed ESCC cases as they receive treatment under local conditions to provide accurate survival estimates. Thirdly, biospecimens from consenting patients will permit etiology and pathogenesis studies to understand mechanisms of ESCC development, which can be correlated with high-quality clinical and epidemiologic data. Finally, we plan to coordinate with other ESCC researchers in eastern and southern Africa to harmonize data collection, and help create a regional consortium in which Malawi can be a founding member and active participant.
Primary Objective: Identify demographic and environmental risk factors for ESCC through a case-control study implemented at KCH and SGH. Hypothesis: Modifiable risk factors contribute significantly to ESCC. These include polycyclic aromatic hydrocarbon (PAH) exposure from various sources, excessively hot beverages, dietary factors such as maize fumonisin and low selenium, and HIV infection.
Secondary Objective: Identify common genetic and epigenetic alterations in germline and somatic DNA associated with ESCC development. Hypothesis: Recurring genetic and epigenetic alterations can facilitate risk stratification, development of early detection biomarkers, and identification of novel treatment strategies.
Procedures
After informed consent and study enrollment, subjects will be interviewed using a structured questionnaire and provide biological samples including saliva, blood, urine, and toenail clippings. Esophageal biopsies will be taken for diagnostic confirmation and to support molecular studies. If patients suspected to have ESCC are enrolled but then pathologically confirmed to have an alternate diagnosis, they will be withdrawn. HIV testing will be offered to all participants, and CD4, HIV RNA, and ART status documented for HIV-infected participants. Exposures will be measured using the questionnaire and laboratory analyses of saliva, blood, urine, and toenail samples. We will collect information on: demographic characteristics; HIV status; tobacco and drug use; alcohol consumption; medical history; family history of cancer; indoor air pollution; occupational history; diet, cooking, and food preservation; beverage history including temperature; farming; signs and symptoms of upper gastrointestinal disease; oral health; anthropometric indices; and reproductive history. To examine correlates with patient outcomes, telephone follow-up to assess vital status will be done every 3 months until 2 years from enrollment. Biological samples will be stored in freezers and transferred to the US only for assays that are currently unavailable in Malawi. Laboratory testing will include serum selenium level, blood and urine testing for PAH exposure, tumor immunohistochemistry assays, salivary DNA isolation for genetic studies, and molecular profiling of ESCC tumors.
Analysis
Sample size will include 300 ESCC cases and 300 controls; 66-68 case control pairs will be enrolled per year, over 3 years, assuming a response rate of 75% in the endoscopy clinic. With 300 case-control pairs, estimated statistical power for an exposure with control population prevalence of 10% and OR 2.0 is 81%, using alpha level 0.05, with higher power for higher control exposure rates and odds ratios. Expected prevalence for key exposures (tobacco and alcohol, hot tea, PAH exposure, selenium deficiency, HIV) is 10-50% in the control population. To assess epidemiologic risk factors for ESCC, we will use logistic regression to estimate odds ratios and 95% confidence intervals for each exposure, while controlling for possible confounders. Survival estimates will be generated using Kaplan-Meyer curves to estimate overall survival at 6, 12 and 24 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300 esophageal cases | – | –diagnosed with histologically confirmed ESCC |
| 300 patient controls | – | –without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Cases Inclusion Criteria
- Controls Inclusion Criteria
- All patients > 18 years of age without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases are eligible to be controls, regardless of age, sex, or place of residence
- Subject able to understand and provide written consent in English or Chichewa
- Able to understand and comply with study procedures for the entire length of the study
Key exclusion criteria (9 listed)
- Cases Exclusion Criteria
- Controls Exclusion Criteria
- All patients > 18 years of age with a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases are ineligible to be controls
- Patients with significant difficulty swallowing
- Mental impairment which precludes provision of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for ESCC - HIV Infection
Time frame: 2 years
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
Survival estimates after ESCC diagnosis in Malawi.
Time frame: 2 years
To assess survival after ESCC diagnosis in Malawi.
Risk factors for ESCC - HIV Infection
Time frame: 2 years
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
Risk factors for ESCC - PAH exposure
Time frame: 2 years
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
Risk factors for ESCC - Dietary factors including fumonisin and selenium
Time frame: 2 years
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
Risk factors for ESCC - Scalding hot beverages and foods,
Time frame: 2 years
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
Risk factors for ESCC - Tobacco and alcohol consumption
Time frame: 2 years
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 secondary outcomes
The common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.
Time frame: 2 years
The germline genetic and epigenetic alterations associated with susceptibility to ESCC.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Background: PubMed 21642993Wu 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.
- Background: PubMed 15761078Parkin 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.
- Background: PubMed 15138356Metzger 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.
- Background: PubMed 16259509Dlamini Z, Bhoola K. Esophageal cancer in African blacks of Kwazulu Natal, South Africa: an epidemiological brief. Ethn Dis. 2005 Autumn;15(4):786-9.
- Background: PubMed 20345007Mlombe 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.
- Background: PubMed 22424105Msyamboza 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.
- Background: PubMed 26245249Munishi 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.
- Background: PubMed 25641622Kayamba 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.
- Background: PubMed 22993631Chen 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.
- Background: PubMed 22876312Wang 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.
- Background: PubMed 24649251Kumagai 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.
- Background: PubMed 22185224Jessri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish Gopal, MD, MPH principal investigator
UNC-CH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for ESCC - HIV Infection (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160209, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.