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

NCT ID: NCT03473795

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

7566 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-16

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Communicable Disease

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaire forms

Intervention Type 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.

Bio-specimen samples

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Bio-specimen samples

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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T. Peter Kingham, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

National Hospital of Abuja (Data collection only)

Abuja, Central Business District, Nigeria

Site Status

Lagos State University Teaching Hospital

Idi-Araba, Lagos, Nigeria

Site Status

Olabisis Onabanjo University Teaching Hospital

Sagamu, Ogun State, Nigeria

Site Status

Federal Medical Centre Owo

Owo, Ondo State, Nigeria

Site Status

University College Hospital

Ibadan, Oyo State, Nigeria

Site Status

Ladoke Akintola University of Technology

Ogbomoso, Oyo State, Nigeria

Site Status

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

Enugu, , Nigeria

Site Status

Lagos State University Teaching Hospital

Ikeja, , Nigeria

Site Status

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)

Ile-Ife, , Nigeria

Site Status

University of Ilorin Teaching Hospitals

Ilorin, , Nigeria

Site Status

University of Maiduguri Teaching Hospital (Data collection only)

Maiduguri, , Nigeria

Site Status

Ondo State Trauma and Surgical Centre

Ondo, , Nigeria

Site Status

Federal Medical Centre Owo

Owo, , Nigeria

Site Status

Countries

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United States Nigeria

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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18-114

Identifier Type: -

Identifier Source: org_study_id

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