The Oxford Risk Factors And Non-Invasive Imaging Study

Last updated: December 5, 2024
Sponsor: University of Oxford
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT05169333
The ORFAN Study
  • Ages 18-99
  • All Genders

Study Summary

ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion Criteria for study Arms 1, 2 and 3:

  • Participant is willing and able to give informed consent for participation in thestudy.

  • Male or Female, aged 18 -99 years.

Inclusion Criteria for study Arm 4:

• Male or Female, aged 18 -99 years.

Exclusion

Exclusion Criteria:

Exclusion Criteria for Study Arms 1, 2 and 3:

  • Unable or unwilling to consent

  • Active cancer

Exclusion Criteria for Study Arm 4:

  • Participation in Study Arms 1, 2 or 3

  • Existing opt-out from use of data for research purposes

Study Design

Total Participants: 250000
Study Start date:
February 23, 2016
Estimated Completion Date:
February 28, 2030

Study Description

The ORFAN registry will include unselected, consecutive patients undergoing CT scans (coronary CT angiograms (CCTA), CT chest, abdomen and pelvis scans) collected at the participating centres. The study will combine imaging data with patient demographics and clinical information (including prospective outcomes) to aid the development and/or validation of new or existing image analysis algorithms and software tools to improve diagnosis, clinical risk discrimination and prediction. Specifically, ORFAN will evaluate the specificity, utility and predictive value of newly developed image analysis methods. ORFAN will recruit and follow-up patients prospectively, linking the index CT scan with blood biomarkers, genetic information as well as information on disease progression (recorded through follow-up CT scans) and clinical outcomes data.

The study will also collect CT scans performed in the past and link them with clinical factors and prospective outcomes data collected after the index scan was performed.

Connect with a study center

  • Flinders University

    Adelaide,
    Australia

    Site Not Available

  • The University of Sydney

    Sydney,
    Australia

    Site Not Available

  • University Hospitals Leuven

    Leuven,
    Belgium

    Site Not Available

  • Fudan University

    Shanghai,
    China

    Site Not Available

  • TEDA International Cardiovascular Hospital

    Tianjin,
    China

    Site Not Available

  • Almaviva Sante - Clinique Axium

    Aix-en-Provence,
    France

    Site Not Available

  • Friedrich-Alexander-Universitat Erlangen-Nurmberg

    Erlangen,
    Germany

    Active - Recruiting

  • University Hospital Ulm

    Ulm,
    Germany

    Site Not Available

  • Lefkos Stavros Clinic

    Athens,
    Greece

    Active - Recruiting

  • MTA-SE Cardiovascular Imaging Research Group

    Budapest,
    Hungary

    Active - Recruiting

  • Centro Cardiologico Monzino IRCCS, University of Milan

    Milan,
    Italy

    Active - Recruiting

  • Oita University

    Ōita,
    Japan

    Active - Recruiting

  • Seoul National University

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Amsterdam Universitair Medische Centra

    Amsterdam,
    Netherlands

    Site Not Available

  • Zuyderland Medical Centre

    Sittard,
    Netherlands

    Site Not Available

  • University of Medicine and Pharmacy of Targu Mures

    Târgu-Mureş,
    Romania

    Active - Recruiting

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi,
    United Arab Emirates

    Site Not Available

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath,
    United Kingdom

    Active - Recruiting

  • Sandwell and West Birmingham Hospitals NHS Trust

    Birmingham,
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Trust

    Birmingham,
    United Kingdom

    Site Not Available

  • Royal Papworth Hospital NHS Trust

    Cambridge,
    United Kingdom

    Active - Recruiting

  • University of Edinburgh, Royal Infirmary

    Edinburgh,
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow,
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds,
    United Kingdom

    Active - Recruiting

  • University Hosptials of Leicester NHS Trust

    Leicester,
    United Kingdom

    Active - Recruiting

  • Liverpool Heart and Chest Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Brompton and Harefield Hospitals

    London,
    United Kingdom

    Active - Recruiting

  • University Hospital of Manchester NHS Foundation Trust

    Manchester,
    United Kingdom

    Site Not Available

  • Milton Keynes University Hospital

    Milton Keynes,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford,
    United Kingdom

    Active - Recruiting

  • Heart and Lung Centre, New Cross Hospital

    Wolverhampton,
    United Kingdom

    Active - Recruiting

  • NIH National Heart, Lunch, and Blood Institute

    Bethesda, Maryland
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota
    United States

    Site Not Available

  • Cleveland Clinic Heart and Vascular Institute

    Cleveland, Ohio
    United States

    Active - Recruiting

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