Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT01415167
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Sponsor:
Prometheus Laboratories
Organization:
Study Overview
Official Title:
Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: