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NCT01415167 Clinical Trial

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

Metastatic Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01415167
Other study ID # 10PLK13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2011
Est. completion date May 2018

Study information
Verified date June 2019
Source Prometheus Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1690
Est. completion date May 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States University of Michigan Health System Ann Arbor Michigan
United States Emory University Winship Cancer Institute Atlanta Georgia
United States University of Colorado Cancer Center Aurora Colorado
United States The Baton Rouge Clinic, AMC Baton Rouge Louisiana
United States Saint Luke's Hospital and Health Network Bethlehem Pennsylvania
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Blumenthal Cancer Center Charlotte North Carolina
United States Rush Pres St Lukes Medical Center Chicago Illinois
United States The Christ Hospital Cancer Center Cincinnati Ohio
United States University of Cincinnati Cancer Institute Cincinnati Ohio
United States University Hospitals Siedman Cancer Center Cleveland Ohio
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Wheaton Franciscan Cancer Care Franklin Wisconsin
United States Hackensack University Medical Center Hackensack New Jersey
United States The Pennsylvania State University and The Milton S. Hershey Medical Center Hershey Pennsylvania
United States University of Hawaii Honolulu Hawaii
United States MD Anderson Cancer Center Houston Texas
United States Indiana University Melvin and Bren Simon Center Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Kansas Hospital Kansas City Kansas
United States Moores UCSD Cancer Center La Jolla California
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States USC Norris Cancer Center Los Angeles California
United States Johns Hopkins Lutherville Maryland
United States Loyola University Medical Center Maywood Illinois
United States University of Miami Miami Florida
United States Mount Sinai Medical Center Comprehensive Cancer Center Miami Beach Florida
United States University of Minnesota Masonic Cancer Center Minneapolis Minnesota
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Columbia University/Herbert Irving Comprehensive Cancer Center New York New York
United States Saint Luke's-Roosevelt Hospital Center New York New York
United States Midwest Cancer Center - Legacy Omaha Nebraska
United States Oncology Specialists, SC Park Ridge Illinois
United States Hillman Cancer Research Pavilion, Div. of Medical Oncology Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Southern California Permanente Medical Group Riverside California
United States Saint Louis University Cancer Center Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States University of Washington Seattle Washington
United States The Research Foundation for The State University of New York Syracuse New York
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States The University of Arizona Cancer Center Tucson Arizona
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Prometheus Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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