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

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ClinicalTrials.gov Identifier: NCT01415167
Recruitment Status : Recruiting
First Posted : August 11, 2011
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease
Metastatic Renal Cell Carcinoma Metastatic Melanoma

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

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Study Start Date : August 2011
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients starting high dose IL-2 or Proleukin therapy are eligible to participate
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415167


Contacts
Contact: Theresa Luna 858-882-8058 tluna@prometheuslabs.com

  Show 45 Study Locations
Sponsors and Collaborators
Prometheus Laboratories
Investigators
Study Chair: Michael Wong, MD MD Anderson
More Information

Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT01415167     History of Changes
Other Study ID Numbers: 10PLK13
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases