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Trial record 7 of 14 for:    15761078 [PUBMED-IDS]

HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi

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ClinicalTrials.gov Identifier: NCT03160209
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief 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.

Condition or disease
Esophageal Squamous Cell Carcinoma

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. Survival estimates after ESCC diagnosis in Malawi. [ Time Frame: 2 years ]
    To assess survival after ESCC diagnosis in Malawi.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Secondary Outcome Measures :
  1. The common somatic genetic and epigenetic alterations in ESCC tumors from Malawi. [ Time Frame: 2 years ]
    To identify and characterize common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.

  2. The germline genetic and epigenetic alterations associated with susceptibility to ESCC. [ Time Frame: 2 years ]
    To identify and characterize germline genetic and epigenetic alterations associated with susceptibility to ESCC.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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
  • Patients with significant difficulty swallowing
  • Mental impairment which precludes provision of informed consent
  • Patients who are unable to provide their past medical history

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): NCT03160209


Contacts
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Contact: Bongani Kaimila, MBBS, MSc +265 1 750 610 bkaimila@unclilongwe.org

Locations
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Malawi
UNC Project, Lighthouse Trust Recruiting
Lilongwe, Malawi
Contact: Sam Phiri, PhD       samphiri@lighthouse.org.mw   
UNC Project Recruiting
Lilongwe, Malawi
Contact: Satish Gopal, MD    265-1-755-056    gopal@med.unc.edu   
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Satish Gopal, MD, MPH UNC-CH

Publications:

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03160209     History of Changes
Other Study ID Numbers: LCCC 1608
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
risk factors
case-control study
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases