Submitted by: N/A Last Updated by: 2013-09-16 16:24:44 Export to PDF

The Observational Registry Collecting Data on Gastroenteropancreatic Neuroendocrine Tumor Patients (GEP-NET Registry)

PHRR130916-000120

11K-1804/11K-2035

Unspecified

The Observational Registry Collecting Data on Gastroenteropancreatic Neuroendocrine Tumor Patients (GEP-NET Registry)

This is a longitudinal, multi center, 8 years regional registry collecting data via a web-based portal in patients with GEPNET (Gastroenteropancreatic Neuroendocrine Tumors). There will be an observation period of at least of 5 years with an initial diagnosis of GEPNET in patients who are alive at time of establishment of GEP-NET Registry. The primary objective is to collect data in standardized way in order to longitudinally assess regional trends on current and evolving diagnostic, treatment, and outcome measures in this GEPNET sub-population, and estimate the incidence and prevalence of GEPNET in Asia Pacific Region. There are no mandated visits or treatment regimens and since this is a registry of observational data there is no formal hypothesis or sample size calculation. The statistical analyses will be mainly descriptive.

Start Date Duration in Months Target Completion Date Actual Completion Date
2012-08-29 64 2017-12-29 2017-12-30

Ongoing

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR
Institution Amount Region
Novartis Healthcare Philippines, Inc. N/A NCR
Name E-Mail Phone Number Postal Address
Jinkie S. Apolonio jinkie.apolonio@novartis.com 02 368 7004 3/F Asian Reinsurance Bldg. Salcedo Cor. Gamboa St. Legaspi Village, Makati City 1226 Philippines
Name E-Mail Phone Number Postal Address
Dr. Joseph Tovera joseph.tovera@novartis.com 02 368 7779 3/F Asian Reinsurance Bldg. Salcedo Cor. Gamboa St. Legaspi Village, Makati City 1226 Philippines
Name Expertise Affiliation
Dennis Lee Sacdalan, MD Medical Oncologist Philippine General Hospital
Andrew Mallen, MD Medical Oncologist Dr. Pablo O. Torre Memorial Hospital
Agnes Evangelista-Gorospe, MD Medical Oncologist St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Dr. Pablo O. Torre Memorial Hospital Dr. Pablo O. Torre Memorial Hospital Research Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

Gastroenteropancreatic Neuroendocrine Tumor (GEPNET)

1. To assess prevalence, incidence, and regional trends in the diagnosis, practical clinical management and outcome measures of GEPNET patients in the Asia Pacific

1. Describe the clinical basis of GEPNET diagnosis in Asia Pacific 2. Describe the place of surgery, local ablative therapy, radiotherapy, nuclear medicine, somatostatin analogues, chemotherapy, and novel targeted therapy in practical clinical management of GEPNET 3. Describe parameters utilized to evaluate tumor response and disease biochemical response in clinical practice 4. Assess the incidence of familial syndromes with GEPNET 5. Evaluate overall and progression free survival

Completed

  • Philippines

Clinical Trial

Unspecified

Unspecified

None

Inclusion Criteria 1. Patients who are alive at time of establishment of GEP-NET Registry and diagnosed with GEPNET in histopathology within 5 years prior to registry entry 2. Adult patients has provided informed consent Exclusion Criteria 1. Inability and unwillingness to give informed consent 2. Registration of patient in another site into GEPNET Registry 3. According to the investigator's opinion the patient is unlikely candidate to obtain long-term follow-up information for reasons of unavailability or severe concomitant illnesses

Observational

Unspecified

Unspecified

Non-randomized

Not Applicable

Unspecified

Not Applicable

The purpose of the study is to collect data to assess regional trends on current and evolving diagnostic, treatment, and outcome measures in the GEPNET subpopulation and estimate the incidence of pravalence of GEPNET

Phase IV

6

6

Unspecified

29 Aug 2012

Utilization Utilization Info
No records found.

Copyright © One Window Project 2018. All rights reserved.