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

June 11, 2019 updated by: Prometheus Laboratories

Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1690

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients starting high dose IL-2 or Proleukin therapy are eligible to participate

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prometheus Laboratories

Investigators

  • Study Chair: Michael Wong, MD, MD Anderson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10PLK13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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