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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Invitation-only

Conditions: Non-Communicable Disease

Treatments: Behavioral: Questionnaire forms; Other: Bio-specimen samples

Study type: Observational

Funder types: Other

Identifiers

NCT03473795

18-114

Details and patient eligibility

About

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.

Enrollment: 7,566 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

7,566 participants in 1 patient group

healthy participants and participants diagnosed with NCDs

Description:

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.

Treatment:

Other: Bio-specimen samples

Behavioral: Questionnaire forms