Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
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.
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.
Phase
N/AInclusion and Exclusion Criteria
- 18 years or older
- Must have received at least one course of high dose IL-2 or Proleukin
- Signed informed consent form
- Prior high dose IL-2 or Proleukin therapy
Sites
-
California
- USC Norris Cancer Center, Los Angeles, California, 90089
- Moores UCSD Cancer Center, La Jolla, California, 92093
-
Arizona
- The University of Arizona Cancer Center, Tuscon, Arizona, 85742
-
Utah
- Huntsman Cancer Institute, Salt Lake City, Utah, 84132
-
Oregon
- Providence Portland Medical Center, Portland, Oregon, 97213
-
Colorado
- University of Colorado Cancer Center, Aurora, Colorado, 80045
-
Nebraska
- Midwest Cancer Center - Legacy, Omaha, Nebraska, 68130
-
Kansas
- University of Kansas Hospital, Kansas City, Kansas, 66160
-
Texas
- MD Anderson Cancer Center, Houston, Texas, 77030
-
Minnesota
- University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, 55455
-
Iowa
- University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242
-
Missouri
- Saint Louis University Cancer Cener, St. Louis, Missouri, 63110
-
Louisiana
- The Baton Rouge Clinic, AMC, Baton Rouge, Louisiana, 70808
-
Illinois
- Loyola University Medical Center, Maywood, Illinois, 60153
- Oncology Specialists, SC, Park Ridge, Illinois, 60068
- Rush Pres St Lukes Medical Center, Chicago, Illinois, 60612
-
Wisconsin
- Wheaton Franciscan Cancer Care, Franklin, Wisconsin, 53132
-
Indiana
- Indiana University Melvin and Bren Simon Center, Indianapolis, Indiana, 46202
-
Ohio
- The Christ Hospital Cancer Center, Cincinnati, Ohio, 45219
-
Georgia
- Emory University Winship Cancer Institute, Atlanta, Georgia, 30322
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