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

NCT03473795 | Active Not Recruiting

• 1 other identifier: 18-114
• Study Type: observational
• Target: 6,990
• Locations: 2 countries
• Sites: 14

Brief Summary

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.

Conditions

Non-Communicable Disease

Keywords

Patient Outcomes; 18-114

Outcome Measures

Primary Outcomes (1)

• # of patients that develope non-communicable diseases in Africa

  5 years

Study Arms (1)

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; Other: Bio-specimen samples

Interventions

Questionnaire forms BEHAVIORAL

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.

healthy participants and participants diagnosed with NCDs

Bio-specimen samples OTHER

Samples can include tissue, blood, urine, saliva, hair and nail clipping.

healthy participants and participants diagnosed with NCDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Duke University: collaborator
• Johns Hopkins University: collaborator

Study Sites (14)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

National Hospital of Abuja (Data collection only)

Abuja, Central Business District, 900103, Nigeria

Location

Lagos State University Teaching Hospital

Idi Araba, Lagos, Nigeria

Location

Olabisis Onabanjo University Teaching Hospital

Sagamu, Ogun State, Nigeria

Location

Federal Medical Centre Owo

Owo, Ondo State, Nigeria

Location

University College Hospital

Ibadan, Oyo State, Nigeria

Location

Ladoke Akintola University of Technology

Ogbomoso, Oyo State, Nigeria

Location

University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu

Enugu, Nigeria

Location

Lagos State University Teaching Hospital

Ikeja, Nigeria

Location

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)

Ile-Ife, Nigeria

Location

University of Ilorin Teaching Hospitals

Ilorin, Nigeria

Location

University of Maiduguri Teaching Hospital (Data collection only)

Maiduguri, 600104, Nigeria

Location

Ondo State Trauma and Surgical Centre

Ondo, Nigeria

Location

Federal Medical Centre Owo

Owo, Nigeria

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Samples can include tissue, blood, urine, saliva, hair and nail clipping.

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• T. Peter Kingham, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 22, 2018
• Study Start: March 16, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1); NG (13)