Spots Global Cancer Trial Database for PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
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Trial Identification
Brief Title: PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Official Title: Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Study ID: NCT01415167
Interventions
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
Moores UCSD Cancer Center, La Jolla, California, United States
USC Norris Cancer Center, Los Angeles, California, United States
Southern California Permanente Medical Group, Riverside, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Mount Sinai Medical Center Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
University of Hawaii, Honolulu, Hawaii, United States
Rush Pres St Lukes Medical Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Oncology Specialists, SC, Park Ridge, Illinois, 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
The Baton Rouge Clinic, AMC, Baton Rouge, Louisiana, United States
Johns Hopkins, Lutherville, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
Midwest Cancer Center - Legacy, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Saint Luke's-Roosevelt Hospital Center, New York, New York, United States
Columbia University/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
The Research Foundation for The State University of New York, Syracuse, New York, United States
Blumenthal Cancer Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, 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
Providence Portland Medical Center, Portland, Oregon, United States
Saint Luke's Hospital and Health Network, Bethlehem, Pennsylvania, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Hillman Cancer Research Pavilion, Div. of Medical Oncology, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Washington, Seattle, Washington, United States
Wheaton Franciscan Cancer Care, Franklin, Wisconsin, United States
Contact Details
Name: Michael Wong, MD
Affiliation: MD Anderson
Role: STUDY_CHAIR
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