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



Status:Recruiting
Conditions:Skin Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2011
End Date:August 2016
Contact:Theresa Luna
Email:tluna@prometheuslabs.com
Phone:858-882-8058

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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.

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.

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
We found this trial at
39
sites
New York, New York 10025
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David McDermott, MD
Phone: 617-632-9270
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Principal Investigator: Ulka Vaishampayan, MD
Phone: 313-576-8495
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
Principal Investigator: Clayton Chong, MD
Phone: 808-691-8548
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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Honolulu, HI
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Brendan Curti, MD
Phone: 503-215-9948
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Mayer Fishman, MD, PhD
Phone: 813-745-3982
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Christopher Lao, MD
Phone: 734-936-0467
University of Michigan Health System The University of Michigan is home to one of the...
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Ann Arbor, MI
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Ajjai Alva, MD
Phone: 734-647-9075
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Atlanta, Georgia 30322
Principal Investigator: David Lawson, MD
Phone: 404-778-5680
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Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Rene Gonzalez, MD
Phone: 720-848-0564
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Aurora, CO
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Baton Rouge, Louisiana 70808
Principal Investigator: Gerald Miletello, MD
Phone: 225-767-0822
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Baton Rouge, LA
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Bethlehem, Pennsylvania 18015
Principal Investigator: Sanjiv Agarwala, MD
Phone: 484-503-4151
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Bethlehem, PA
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Charlotte, North Carolina 28204
Principal Investigator: Asim Amin, MD
Phone: 704-355-5407
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Charlotte, NC
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Chicago, Illinois 60612
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Chicago, IL
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Cincinnati, Ohio 45219
Principal Investigator: Philip Leming, MD
Phone: 513-585-0844
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Cincinnati, OH
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Cleveland, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Michael Morse, MD
Phone: 919-684-6044
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Franklin, Wisconsin 53132
Principal Investigator: Jonathan Treisman, MD
Phone: 414-427-2396
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Franklin, WI
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Robert Alter, MD
Phone: 551-996-5900
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Houston, Texas 77030
Principal Investigator: Sapna Patel, BA, MD
Phone: 713-792-7641
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Houston, TX
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Indianapolis, Indiana 46202
Principal Investigator: Theodore Logan, MD
Phone: 317-948-7576
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Mohammed Milhem, MD
Phone: 319-353-8775
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Kansas City, Kansas 66160
Principal Investigator: Gary Doolittle, MD
Phone: 913-945-6594
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Kansas City, KS
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La Jolla, California 92093
Principal Investigator: Gregory Daniels, MD
Phone: 858-534-3804
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La Jolla, CA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Los Angeles, California 90033
Principal Investigator: Michael Wong, MD, PhD, FRCPC
Phone: 323-865-0802
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Los Angeles, CA
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Lutherville, Maryland 21093
Principal Investigator: William Sharfman, MD
Phone: 410-583-2983
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Lutherville, MD
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Joseph Clark, MD
Phone: 708-327-3221
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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Miami Beach, Florida 33140
Principal Investigator: Jose Lutzky, MD
Phone: 305-674-2625
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Miami Beach, FL
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Minneapolis, Minnesota 55455
Principal Investigator: Sherman Holtan, MD
Phone: 612-624-3238
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Minneapolis, MN
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New Brunswick, New Jersey 08903
Principal Investigator: Howard Kaufman, MD
Phone: 732-235-8675
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New York, New York 10032
Principal Investigator: Bret Taback, MD
Phone: 212-305-1317
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New York, NY
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Omaha, Nebraska 68130
Principal Investigator: Ralph Hauke, MD
Phone: 402-691-6971
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Omaha, NE
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Park Ridge, Illinois 60068
Principal Investigator: Sigrun Hallmeyer, MD
Phone: 847-268-8574
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Park Ridge, IL
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Pittsburgh, Pennsylvania 15232
Principal Investigator: John Kirkwood, MD
Phone: 412-623-6121
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Salt Lake City, Utah 84112
Principal Investigator: Neeraj Agarwal, MD
Phone: 801-213-2780
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Salt Lake City, UT
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St. Louis, Missouri 63110
Principal Investigator: John Richart, MD
Phone: 314-268-7059
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St. Louis, MO
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Tuscon, Arizona 85742
Principal Investigator: Parminder Singh, MD
Phone: 520-694-2873
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Tuscon, AZ
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Winston Salem, North Carolina 27103
Principal Investigator: Perry Shen, MD
Phone: 336-713-3155
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Winston Salem, NC
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