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Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02457962
Collaborator
(none)
15,000
Enrollment
1
Location
120
Duration (Months)
125
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon/proton therapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    15000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study
    Study Start Date :
    Apr 1, 2015
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. analyze acute and late toxicities using CTCAE 4.03 [Patients will be followed for the duration of their life, an expected average of 20 years]

    2. analyze quality of life using LASA-3 and FACT-E [Patients will be followed for the duration of their life, an expected average of 20 years]

    Secondary Outcome Measures

    1. analyze local control through tumor assessments [Patients will be followed for the duration of their life, an expected average of 20 years]

    2. analyze survival by contacting patient and EMR (electronic medical record) review [Patients will be followed for the duration of their life, an expected average of 20 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Treated with photon/proton at Mayo Clinic Rochester in Radiation Oncology

    2. Radiation therapy for curative intent

    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Nadia N Laack, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nadia N. Laack, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02457962
    Other Study ID Numbers:
    • 15-000136
    First Posted:
    May 29, 2015
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Jul 13, 2022