Clinical trial NCT03473795: Developing Non-Communicable Disease Registries in Africa : A Step Towards Providing Quality Data for Improving Patient Outcomes
Official title: Developing Non-Communicable Disease Registries in Africa: A Step Towards Providing Quality Data for Improving Patient Outcomes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Non-Communicable Disease
Keywords: Patient Outcomes
18-114
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Duke University
name: Johns Hopkins University
First posted: 2018-03-22
Enrollment: 7566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: # of patients that develope non-communicable diseases in Africa
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Abuja
country: Nigeria
facility: National Hospital of Abuja (Data collection only)
state: Central Business District
city: Idi-Araba
country: Nigeria
facility: Lagos State University Teaching Hospital
state: Lagos
city: Sagamu
country: Nigeria
facility: Olabisis Onabanjo University Teaching Hospital
state: Ogun State
city: Owo
country: Nigeria
facility: Federal Medical Centre Owo
state: Ondo State
city: Ibadan
country: Nigeria
facility: University College Hospital
state: Oyo
city: Ogbomoso
country: Nigeria
facility: Ladoke Akintola University of Technology
state: Oyo
city: Enugu
country: Nigeria
facility: University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
city: Ikeja
country: Nigeria
facility: Lagos State University Teaching Hospital
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
city: Ilorin
country: Nigeria
facility: University of Ilorin Teaching Hospitals
city: Maiduguri
country: Nigeria
facility: University of Maiduguri Teaching Hospital (Data collection only)
city: Ondo
country: Nigeria
facility: Ondo State Trauma and Surgical Centre
city: Owo
country: Nigeria
facility: Federal Medical Centre Owo
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: T. Peter Kingham, MD
role: PRINCIPAL_INVESTIGATOR
References: