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The Moli-sani Study

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ClinicalTrials.gov Identifier: NCT03242109
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Licia Iacoviello, Neuromed IRCCS

Brief Summary:

Cardiovascular disease and malignancies account for more than 70% of all causes of mortality and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle, that often defines the line between health and sickness. So far studies aiming at identifying risk factors have mainly come from Northern Europe and the USA. It was to understand this balance between genetics and environmental determinants better, and to tailor appropriate preventive strategies for Italian and other Southern European populations, that the Moli-sani study was launched, transforming a small Italian region into a large scientific laboratory: the "Molise lab".

Each participant received a thorough medical check-up at no cost to either him/her or the national health service, resulting in thousands of hours of free public health care. With a completely computerized system, Moli-sani is a "paperless" study, in which researchers and participants communicate using recently developed technologies such as mobile phone text messages (SMS). The biological data bank (the "MoliBank") is one of the largest in Europe. Paying particular attention towards innovation and new technologies, the Moli-sani study has placed itself at the cutting edge of a new paradigm crossing research and prevention


Condition or disease
Cardiovascular Diseases Cardiovascular Risk Factor Cancer Neurodegenerative Diseases Diabetes Pulmonary Disease

Detailed Description:
The cohort of the Moli-sani study has recruited 24,325 persons, aged >35 years, resident in the Molise region.The latter covers an area of 4,438 Km2, including 136 towns. Participants are recruited from city-hall registries by a multistage sampling. Firstly townships were sampled in three major areas of Molise region, starting from the main cities (Campobasso, Termoli, Isernia) by cluster sampling, then, within each township, participants are selected by simple random sampling, using electronically generated numbers.Exclusion criteria are pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form. All subjects identified are sent a letter inviting them to participate in the project, followed a few days later by a phone call. The recruitment started in the area of Campobasso, then it moved to the areas of Termoli.

Study Type : Observational
Actual Enrollment : 24325 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Epidemiological Study of Risk Factors for Cardiovascular Disease and Tumors in an Adult Population of the Molise Region
Actual Study Start Date : March 1, 2005
Actual Primary Completion Date : April 30, 2010
Actual Study Completion Date : April 30, 2010



Primary Outcome Measures :
  1. Primary cardiovascular diseases [ Time Frame: 10 years ]
    Primary fatal and nonfatal incident cases of CHD (unstable angina, myocardial infarction, coronary revascularization and sudden death for unspecified cardiac event) and cerebrovascular disease that occurred in the cohort during follow-up

  2. Cancer [ Time Frame: 10 years ]
    Primary fatal and nonfatal incident cases of cancer that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

  3. Heart failure [ Time Frame: 10 years ]
    Primary fatal and nonfatal incident cases of heart failure that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

  4. Atrial fibrillation [ Time Frame: 10 years ]
    Primary fatal and nonfatal incident cases of atrial fibrillation that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

  5. Diabetes [ Time Frame: 10 years ]
    Primary incident cases of diabetes that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry or pharmacological prescription registry. Diabetes onset is defined as blood glucose ≥126 mg/dl or by use of specific pharmacological treatment


Biospecimen Retention:   Samples With DNA
Blood samples obtained from participants who had fasted overnight and had refrained from smoking for at least 6 h and stored in liquid nitrogen in the Biological bank of the Moli-sani study.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Moli-sani is a population-based cohort study that recruited, between March 2005 and April 2010, 24,325 men and women at random from individuals aged 35 years or older resident in the Molise region, to investigate genetic and environmental risk factors for cardiovascular, cerebrovascular and tumour diseases.
Criteria

Inclusion Criteria:

  • Resident in the Molise region (Italy), aged >35.

Exclusion Criteria:

  • pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form.

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): NCT03242109


Locations
Italy
Irccs Neuromed
Pozzilli, Italy, 86067
Sponsors and Collaborators
Neuromed IRCCS
Investigators
Principal Investigator: Licia Iacoviello, MD, PhD Department of Epidemiology and Prevention, IRCCS Neuromed

Publications of Results:
Responsible Party: Licia Iacoviello, MD, PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03242109     History of Changes
Other Study ID Numbers: 50/17
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: sumbmission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Upon request
Access Criteria: Approval by the Moli-sani study Scientific committee

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Cardiovascular Diseases
Neurodegenerative Diseases
Respiratory Tract Diseases
Nervous System Diseases