Clinical trial NCT01708408: The MURDOCK Study Registry and Biorepository Horizon 1.5
Official title: Measurement to Understand Reclassification of Disease of Cabarrus/Kannapolis the MURDOCK Study Registry and Biorepository Horizon 1.5
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Disease
Healthy Volunteers
Keywords: biorepository
biobank
registry
community
biospecimens
volunteers
chronic disease
longitudinal
blood
electronic health records
follow-up
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Community Registry and Biorepository is designed to create a community registry and biorepository populated by approximately 50,000 residents of Cabarrus County and/or the city of Kannapolis in North Carolina.

Brief summary: The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a large-scale community registry and biorepository that can be used as a vehicle for future health services, epidemiologic, clinical trials and other omics-related research.

Detailed description: The MURDOCK Study Community Registry and Biorepository's activities include enrolling approximately 50,000 participants who live in Cabarrus County and/or Kannapolis, North Carolina. Participants must consent to (1) use of the data provided by the participant through completion of the Participant Registry Questionnaire for epidemiologic population characterization, (2) annual contact to update their MURDOCK Horizon 1.5 database record, (3) release of their medical information, including but not limited to demographic information, problem lists, medications, social and family history, and results of laboratory and other testing modalities from pre-existing paper or electronic health records or electronic health records that may become available in the future, (4) provision of a blood and urine sample, and (5) contact up to four times/year to request participation in additional research studies.

Eligibility criteria: Inclusion Criteria:

1. A resident of Cabarrus County and/or the city of Kannapolis (and surrounding regions) for 6 or more months of the year
2. At least 18 years of age
3. Able to understand and give written informed consent, or have a legal guardian or caregiver present to give informed consent by proxy (assent from a participant between ages 12-18 will be obtained when their parent or legal guardian consents on their behalf).
4. Willing and able to participate in all 5 components of the registry and biorepository as described above in Section III

Exclusion Criteria:

1. There are no exclusions to participation if all inclusion criteria have been met.

Primary outcomes:
measure: The MURDOCK Study Registry and Biorepository Horizon 1.5
timeFrame: Upto 119 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Duke Clinical Translational Science Institute-MURDOCK Study
state: North Carolina
Study officials:
affiliation: Duke University
name: Kristin M Newby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tenenbaum JD, Christian V, Cornish MA, Dolor RJ, Dunham AA, Ginsburg GS, Kraus VB, McHutchison JG, Nahm ML, Newby LK, Svetkey LP, Udayakumar K, Califf RM. The MURDOCK Study: a long-term initiative for disease reclassification through advanced biomarker discovery and integration with electronic health records. Am J Transl Res. 2012;4(3):291-301. Epub 2012 Jul 23.