Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Details

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

Metastatic Renal Cell Carcinoma Metastatic Melanoma Carcinoma, Renal Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years or older
  • Must have received at least one course of high dose IL-2 or Proleukin
  • Signed informed consent form

You CAN'T join if...

  • Prior high dose IL-2 or Proleukin therapy

Locations

  • Moores UCSD Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Southern California Permanente Medical Group accepting new patients
    Riverside California 92505 United States
  • USC Norris Cancer Center accepting new patients
    Los Angeles California 90089 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Prometheus Laboratories
ID
NCT01415167
Study Type
Observational
Last Updated
February 2017