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PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Sponsor
Prometheus Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01415167
Collaborator
(none)
1,690
Enrollment
45
Locations
81
Actual Duration (Months)
37.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this registry is to collect information on patients who are receiving treatment with Proleukin in an organized way, and to learn more about patient care during and after treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The PROCLAIM Registry is a US-based, multicenter Registry designed to establish a high quality observational database of real-world clinical data on HD IL-2 when used to treat patients with mRCC, mM or other malignancies. The Registry will not, in any way, suggest changes in the treatment or management of the patients enrolled in the Registry. Therefore, physicians will continue to manage and treat patients according to standard of care and their own judgment.

    The PROCLAIM Registry will start with a retrospective pilot data collection from a de-identified finite number of patient cases abstracted from their existing medical charts. The features collected will be identical to those planned for the prospective registry. The resulting database will be used to formulate hypotheses to be tested using the prospective registry database. Patients utilized in the retrospective analysis will be excluded from the prospective portion of the Registry.

    In the prospective portion of the Registry, sites will enroll patients who are expected to start a course of HD IL-2 therapy. Once enrolled, the patient must receive at least one dose of HD IL-2 to remain in the Registry. Patients will be treated and followed according to the site's standard of care. This Registry will in no way induce changes in the management of individual patients. Clinical data features will be entered into an Electronic Data Capture (EDC) system, and organized into a registry database.

    The data contained in the registry database will be observational data. The PROCLAIM Registry does not stipulate patient care, specific visits or interventions but merely surveys standardized parameters regarding HD IL-2 and associated therapies as they are applied by treatment centers. The collection of standard data over time permits the evaluation of trends in patient survival and subsequent therapy exposure. The database will be used to answer future queries formulated by researchers.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1690 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
    Actual Study Start Date :
    Aug 1, 2011
    Actual Primary Completion Date :
    Apr 1, 2018
    Actual Study Completion Date :
    May 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. A source of observational data that can be used to report and query patient care patterns, clinical outcomes and trends from high dose IL-2 or Proleukin therapy in treating malignant melanoma, or renal cell carcinoma or other malignancies. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years or older

    • Must have received at least one course of high dose IL-2 or Proleukin

    • Signed informed consent form

    Exclusion Criteria:
    • Prior high dose IL-2 or Proleukin therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Arizona Cancer Center Tucson Arizona United States 85742
    2 Moores UCSD Cancer Center La Jolla California United States 92093
    3 USC Norris Cancer Center Los Angeles California United States 90089
    4 Southern California Permanente Medical Group Riverside California United States 92505
    5 University of Colorado Cancer Center Aurora Colorado United States 80045
    6 Mount Sinai Medical Center Comprehensive Cancer Center Miami Beach Florida United States 33140
    7 University of Miami Miami Florida United States 33136
    8 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    9 Emory University Winship Cancer Institute Atlanta Georgia United States 30322
    10 University of Hawaii Honolulu Hawaii United States 96822
    11 Rush Pres St Lukes Medical Center Chicago Illinois United States 60612
    12 Loyola University Medical Center Maywood Illinois United States 60153
    13 Oncology Specialists, SC Park Ridge Illinois United States 60068
    14 Indiana University Melvin and Bren Simon Center Indianapolis Indiana United States 46202
    15 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    16 University of Kansas Hospital Kansas City Kansas United States 66160
    17 The Baton Rouge Clinic, AMC Baton Rouge Louisiana United States 70808
    18 Johns Hopkins Lutherville Maryland United States 21093
    19 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    20 University of Michigan Health System Ann Arbor Michigan United States 48109
    21 University of Michigan Ann Arbor Michigan United States 48109
    22 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    23 University of Minnesota Masonic Cancer Center Minneapolis Minnesota United States 55455
    24 Saint Louis University Cancer Center Saint Louis Missouri United States 63110
    25 Midwest Cancer Center - Legacy Omaha Nebraska United States 68130
    26 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    27 Hackensack University Medical Center Hackensack New Jersey United States 07601
    28 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    29 Saint Luke's-Roosevelt Hospital Center New York New York United States 10019
    30 Columbia University/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    31 The Research Foundation for The State University of New York Syracuse New York United States 13210
    32 Blumenthal Cancer Center Charlotte North Carolina United States 28203
    33 Duke University Medical Center Durham North Carolina United States 27705
    34 Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157
    35 The Christ Hospital Cancer Center Cincinnati Ohio United States 45219
    36 University of Cincinnati Cancer Institute Cincinnati Ohio United States 45267
    37 University Hospitals Siedman Cancer Center Cleveland Ohio United States 44106
    38 Providence Portland Medical Center Portland Oregon United States 97213
    39 Saint Luke's Hospital and Health Network Bethlehem Pennsylvania United States 18015
    40 The Pennsylvania State University and The Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    41 Hillman Cancer Research Pavilion, Div. of Medical Oncology Pittsburgh Pennsylvania United States 15232
    42 MD Anderson Cancer Center Houston Texas United States 77030
    43 Huntsman Cancer Institute Salt Lake City Utah United States 84132
    44 University of Washington Seattle Washington United States 98195
    45 Wheaton Franciscan Cancer Care Franklin Wisconsin United States 53132

    Sponsors and Collaborators

    • Prometheus Laboratories

    Investigators

    • Study Chair: Michael Wong, MD, MD Anderson

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prometheus Laboratories
    ClinicalTrials.gov Identifier:
    NCT01415167
    Other Study ID Numbers:
    • 10PLK13
    First Posted:
    Aug 11, 2011
    Last Update Posted:
    Jun 13, 2019
    Last Verified:
    Jun 1, 2019
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Jun 13, 2019