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

Non-Communicable Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03473795
• Other study ID #: 18-114
• Status: Enrolling by invitation
• Start date: March 16, 2018
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-Communicable Disease
• Noncommunicable Diseases

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Duke University, Johns Hopkins University

Countries where clinical trial is conducted

United States,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	# of patients that develope non-communicable diseases in Africa		5 years

External Links

•   Memorial Sloan Kettering Cancer Center