Developing Non-Communicable Disease Registries in Africa : A Step Towards Providing Quality Data for Improving Patient Outcomes

Developing Non-Communicable Disease Registries in Africa: A Step Towards Providing Quality Data for Improving Patient Outcomes

This umbrella protocol seeks to develop robust data registries for non-communicable diseases (NCDs) in sub-Saharan Africa (SSA) with the aim of providing accurate and comprehensive data for the evaluation of such diseases in sub-Saharan African countries.Healthy volunteers will be included in the study for comparison.

Additionally, the investigators aim to describe the gut microbiome community diversity of a cohort of community dwelling Nigerians and compare with CRC patients in Nigerian and at MSK. We will collect stool for microbiome and metabolomic analysis from community dwelling persons in the catchment area of ARGO facilities in Nigeria while contemporaneously administering an extensive medical and environmental exposure questionnaire.

Study Overview

• Status: Enrolling by invitation
• Conditions: Non-Communicable Disease
• Intervention / Treatment: Behavioral: Questionnaire forms; Other: Bio-specimen samples

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Nigeria
  • Enugu, Nigeria
    • University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
  • Ikeja, Nigeria
    • Lagos State University Teaching Hospital
  • Ile-Ife, Nigeria
    • Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
  • Ilorin, Nigeria
    • University of Ilorin Teaching Hospitals
  • Maiduguri, Nigeria, 600104
    • University of Maiduguri Teaching Hospital (Data collection only)
  • Ondo, Nigeria
    • Ondo State Trauma and Surgical Centre
  • Owo, Nigeria
    • Federal Medical Centre Owo
  • Central Business District
    • Abuja, Central Business District, Nigeria, 900103
      • National Hospital of Abuja (Data collection only)
  • Lagos
    • Idi-Araba, Lagos, Nigeria
      • Lagos State University Teaching Hospital
  • Ogun State
    • Sagamu, Ogun State, Nigeria
      • Olabisis Onabanjo University Teaching Hospital
  • Ondo State
    • Owo, Ondo State, Nigeria
      • Federal Medical Centre Owo
  • Oyo
    • Ibadan, Oyo, Nigeria
      • University College Hospital
    • Ogbomoso, Oyo, Nigeria
      • Ladoke Akintola University of Technology
• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be accrued in medical clinics in Africa as determined by the local investigators and local research staff.

Description

Inclusion Criteria:

• Age 18 and older.
• Suspected or confirmed diagnosis of a non-communicable disease. OR
• Healthy volunteers/no confirmed diagnosis for comparison.

Exclusion Criteria:

• Participants unwilling to sign consent.
• Participants under the age of 18

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

healthy participants and participants diagnosed with NCDs; This protocol will entail prospective collection of data on healthy participants and participants diagnosed with NCDs managed at collaborating institutions in SSA. Information to be obtained includes socio-demographic data, risk factors, disease-specific data, investigation and treatment details, as well as findings during follow-up. Particular reference will be made to outcome measures such as local and distant recurrence, survival and mortality. Follow-up data will be updated during clinic visits and also via phone calls.

Behavioral: Questionnaire forms; The questionnaires will include information such as socio-demographic data, risk factors, disease specific data, investigation and treatment details as well as findings during followup. Particular reference will be made to outcome measures such as local and distant recurrence, survival and mortality.; Other: Bio-specimen samples; Samples can include tissue, blood, urine, saliva, hair and nail clipping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
# of patients that develope non-communicable diseases in Africa	5 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Johns Hopkins University; Duke University
• Investigators: Principal Investigator: T. Peter Kingham, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient Outcomes; 18-114
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 18-114 (Memorial Sloan Kettering Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No