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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03473795
Other study ID # 18-114
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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