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

This study is currently recruiting participants.
Verified March 2014 by Prometheus Laboratories
Sponsor:
Information provided by (Responsible Party):
Prometheus Laboratories
ClinicalTrials.gov Identifier:
NCT01415167
First received: August 9, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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
Metastatic Renal Cell Carcinoma
Metastatic Melanoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Resource links provided by NLM:


Further study details as provided by Prometheus Laboratories:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: August 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415167

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

  Show 36 Study Locations
Sponsors and Collaborators
Prometheus Laboratories
Investigators
Principal Investigator: James Lowder, MD Prometheus Laboratories
  More Information

No publications provided

Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT01415167     History of Changes
Other Study ID Numbers: 10PLK13
Study First Received: August 9, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 22, 2014