Metastatic Renal Cell CarcinomaNCT01415167
PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
An observational study of Metastatic Renal Cell Carcinoma and Metastatic Melanoma, run by Prometheus Laboratories at 45 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Metastatic Melanoma
- How many people
- 1,690 participants
- Where
- 45 sitesUnited States
- Study dates
- Aug 2011to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients starting high dose IL-2 or Proleukin therapy are eligible to participate
Who may be able to join
- 18 years or older
- Must have received at least one course of high dose IL-2 or Proleukin
- Signed informed consent form
Who cannot join
- Prior high dose IL-2 or Proleukin therapy
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana, 70808
Saint Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Blumenthal Cancer Center
Charlotte, North Carolina, 28203
Rush Pres St Lukes Medical Center
Chicago, Illinois, 60612
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267
University Hospitals Siedman Cancer Center
Cleveland, Ohio, 44106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27705
Wheaton Franciscan Cancer Care
Franklin, Wisconsin, 53132
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Hawaii
Honolulu, Hawaii, 96822
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Hospital
Kansas City, Kansas, 66160
Moores UCSD Cancer Center
La Jolla, California, 92093
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Norris Cancer Center
Los Angeles, California, 90089
Johns Hopkins
Lutherville, Maryland, 21093
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Saint Luke's-Roosevelt Hospital Center
New York, New York, 10019
Columbia University/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Midwest Cancer Center - Legacy
Omaha, Nebraska, 68130
Oncology Specialists, SC
Park Ridge, Illinois, 60068
Hillman Cancer Research Pavilion, Div. of Medical Oncology
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center
Portland, Oregon, 97213
Southern California Permanente Medical Group
Riverside, California, 92505
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
University of Washington
Seattle, Washington, 98195
Saint Louis University Cancer Center
St Louis, Missouri, 63110
The Research Foundation for The State University of New York
Syracuse, New York, 13210
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
The University of Arizona Cancer Center
Tucson, Arizona, 85742
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Carcinoma, Renal Cell, Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prometheus Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Wong, MD, Study chair, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415167
- Sponsor's protocol ID
- 10PLK13
- Status last verified
- Jun 2019
- First submitted
- 9 Aug 2011
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Fishman M, Dutcher JP, Clark JI, Alva A, Miletello GP, Curti B, Agarwal N, Hauke R, Mahoney KM, Moon H, Treisman J, Tykodi SS, Daniels G, Morse MA, Wong MKK, Kaufman H, Gregory N, McDermott DF. Overall survival by clinical risk category for high dose interleukin-2 (HD IL-2) treated patients with metastatic renal cell cancer (mRCC): data from the PROCLAIMSM registry. J Immunother Cancer. 2019 Mar 27;7(1):84. doi: 10.1186/s40425-019-0567-3.
PubMed 30917871Curti B, Daniels GA, McDermott DF, Clark JI, Kaufman HL, Logan TF, Singh J, Kaur M, Luna TL, Gregory N, Morse MA, Wong MKK, Dutcher JP. Improved survival and tumor control with Interleukin-2 is associated with the development of immune-related adverse events: data from the PROCLAIMSM registry. J Immunother Cancer. 2017 Dec 19;5(1):102. doi: 10.1186/s40425-017-0307-5.
PubMed 29254506
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
- ClinicalTrials.gov ID
- NCT01415167
- Acronym / sponsor ID
- 10PLK13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,690 participants (actual)
- Lead sponsor
- Prometheus LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients starting high dose IL-2 or Proleukin therapy are eligible to participate
Key inclusion criteria (3 listed)
- 18 years or older
- Must have received at least one course of high dose IL-2 or Proleukin
- Signed informed consent form
Key exclusion criteria (1 listed)
- Prior high dose IL-2 or Proleukin therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Derived from this study: PubMed 30917871Fishman M, Dutcher JP, Clark JI, Alva A, Miletello GP, Curti B, Agarwal N, Hauke R, Mahoney KM, Moon H, Treisman J, Tykodi SS, Daniels G, Morse MA, Wong MKK, Kaufman H, Gregory N, McDermott DF. Overall survival by clinical risk category for high dose interleukin-2 (HD IL-2) treated patients with metastatic renal cell cancer (mRCC): data from the PROCLAIMSM registry. J Immunother Cancer. 2019 Mar 27;7(1):84. doi: 10.1186/s40425-019-0567-3.
- Derived from this study: PubMed 29254506Curti B, Daniels GA, McDermott DF, Clark JI, Kaufman HL, Logan TF, Singh J, Kaur M, Luna TL, Gregory N, Morse MA, Wong MKK, Dutcher JP. Improved survival and tumor control with Interleukin-2 is associated with the development of immune-related adverse events: data from the PROCLAIMSM registry. J Immunother Cancer. 2017 Dec 19;5(1):102. doi: 10.1186/s40425-017-0307-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wong, MD study chair
MD Anderson
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma and Metastatic Melanoma, run by Prometheus Laboratories at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.