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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03242109
Other study ID # 50/17
Secondary ID
Status Completed
Phase N/A
First received July 31, 2017
Last updated August 2, 2017
Start date March 1, 2005
Est. completion date April 30, 2010

Study information

Verified date July 2017
Source Neuromed IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 24325
Est. completion date April 30, 2010
Est. primary completion date April 30, 2010
Accepts healthy volunteers
Gender All
Age group 35 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Italy Irccs Neuromed Pozzilli

Sponsors (1)

Lead Sponsor Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bonaccio M, Di Castelnuovo A, Costanzo S, de Curtis A, Persichillo M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; MOLI-SANI study Investigators. Mean platelet volume is associated with lower risk of overall and non-vascular mortality in a general p — View Citation

Pounis G, Tabolacci C, Costanzo S, Cordella M, Bonaccio M, Rago L, D'Arcangelo D, Filippo Di Castelnuovo A, de Gaetano G, Donati MB, Iacoviello L, Facchiano F; Moli-sani study investigators. Reduction by coffee consumption of prostate cancer risk: Evidenc — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary cardiovascular diseases 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 10 years
Primary Cancer 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 10 years
Primary Heart failure 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 10 years
Primary Atrial fibrillation 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 10 years
Primary Diabetes 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 10 years
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