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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473795
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2018
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment
Non-Communicable Disease Behavioral: Questionnaire forms Other: Bio-specimen samples

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Developing Non-Communicable Disease Registries in Africa: A Step Towards Providing Quality Data for Improving Patient Outcomes
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. # of patients that develope non-communicable diseases in Africa [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Samples can include tissue, blood, urine, saliva, hair and nail clipping.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473795


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Nigeria
Lagos State University Teaching Hospital
Idi-Araba, Lagos, Nigeria
Olabisis Onabanjo University Teaching Hospital
Sagamu, Ogun State, Nigeria
Federal Medical Centre Owo
Owo, Ondo State, Nigeria
University College Hospital
Ibadan, Oyo, Nigeria
Ladoke Akintola University of Technology
Ogbomoso, Oyo, Nigeria
University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
Enugu, 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
Ondo State Trauma and Surgical Centre
Ondo, Nigeria
Federal Medical Centre Owo
Owo, Nigeria
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: T. Peter Kingham, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03473795    
Other Study ID Numbers: 18-114
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Patient Outcomes
18-114
Additional relevant MeSH terms:
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Noncommunicable Diseases
Disease Attributes
Pathologic Processes