CancerECHORNNCT01994811
Eastern Caribbean Health Outcomes Research Network (ECHORN)
An observational study of Cancer and Cardiovascular Disease, run by Yale University at 4 sites in 4 countries.
Trial summary
The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cardiovascular Disease, Diabetes
- How many people
- 2,961 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2013to 14 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population-based prospective cohort is comprised of adults aged 40 and older living in four countries: Puerto Rico (PR), Barbados (BB), the US Virgin Islands (USVI), and Trinidad and Tobago (TT).
Who may be able to join
- Greater than or equal to 40 years of age
- English or Spanish language speaking
- Resident of island at least 10 years
- Able to provide informed consent
- Non-institutionalized at the time of data collection
- Stable contact/residential information
- No plans to relocate from island within the next 5 years
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Barbados1 site
University of the West Indies, Cave Hill Campus
Bridgetown, BB 11000
Puerto Rico1 site
University of Puerto Rico Medical Sciences Campus
San Juan, 00936-5067
Trinidad and Tobago1 site
University of the West Indies, St. Augustine Campus
Saint Augustine, West Indies
Virgin Islands1 site
University of the Virgin Islands
Charlotte Amalie, Virgin Islands, 00802-9990
About this study
The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.
Read the detailed description
The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad \& Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and potential risk factors associated with the development of heart disease, cancer, and diabetes and (2) To enhance health outcomes research leadership capacity in the region through a series of dedicated activities locally and abroad. ECHORN will expand clinical research with racial/ethnic minority populations in a transitioning part of the globe now threatened with an epidemic of noncommunicable chronic diseases (NCD). ECHORN's findings will have direct implications for the health disparities research and policy agenda in the mainland United States. In the long term, the links ECHORN will facilitate with local health policy delegations and global strategic organizational partners will promote the translation of research to improve health outcomes across the region. The collection and storage of biological specimens will also contribute to national biomonitoring projects and has the potential to identify unique risk and protective factors in the development of NCD.
- Conditions
- Cancer, Cardiovascular Disease, Diabetes
- Keywords
- cancer, cardiovascular disease, diabetes
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of non-communicable diseases
Prevalence of non-communicable diseases, including cancer, heart disease and diabetes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startApr 2013
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,961 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Marcella Nunez-Smith, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994811
- Sponsor's protocol ID
- 1108008959
- Other IDs
- 5U24MD006938
- Acronym
- ECHORN
- Status last verified
- Jul 2022
- First submitted
- 19 Nov 2013
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Data Access and Scientific Review Committee (DASR), was been established to oversee requests for research collaboration (e.g. ancillary studies, secondary data analyses, etc.) to ensure they are within the scope of ECHORN's research mandate. Per the ECHORN Data Access Policy, de-identified, limited ECHORN datasets have been made available for public access.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eastern Caribbean Health Outcomes Research Network (ECHORN)
- ClinicalTrials.gov ID
- NCT01994811
- Acronym / sponsor ID
- ECHORN / 1108008959
- Conditions
- Cancer, Cardiovascular Disease, Diabetes
- Keywords
- cancer, cardiovascular disease, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,961 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Apr 2013 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.
Detailed description
The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad \& Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and potential risk factors associated with the development of heart disease, cancer, and diabetes and (2) To enhance health outcomes research leadership capacity in the region through a series of dedicated activities locally and abroad. ECHORN will expand clinical research with racial/ethnic minority populations in a transitioning part of the globe now threatened with an epidemic of noncommunicable chronic diseases (NCD). ECHORN's findings will have direct implications for the health disparities research and policy agenda in the mainland United States. In the long term, the links ECHORN will facilitate with local health policy delegations and global strategic organizational partners will promote the translation of research to improve health outcomes across the region. The collection and storage of biological specimens will also contribute to national biomonitoring projects and has the potential to identify unique risk and protective factors in the development of NCD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population-based prospective cohort is comprised of adults aged 40 and older living in four countries: Puerto Rico (PR), Barbados (BB), the US Virgin Islands (USVI), and Trinidad and Tobago (TT).
Key inclusion criteria (7 listed)
- Greater than or equal to 40 years of age
- English or Spanish language speaking
- Resident of island at least 10 years
- Able to provide informed consent
- Non-institutionalized at the time of data collection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of non-communicable diseases
Time frame: 5 years
Prevalence of non-communicable diseases, including cancer, heart disease and diabetes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: Yes. A Data Access and Scientific Review Committee (DASR), was been established to oversee requests for research collaboration (e.g. ancillary studies, secondary data analyses, etc.) to ensure they are within the scope of ECHORN's research mandate. Per the ECHORN Data Access Policy, de-identified, limited ECHORN datasets have been made available for public access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcella Nunez-Smith, MD, MHS principal investigator
Yale University
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cardiovascular Disease, run by Yale University at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Barbados, Puerto Rico, Trinidad and Tobago, Virgin Islands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of non-communicable diseases (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.