PLA for HCC and Esophageal ca Serum
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|ClinicalTrials.gov Identifier: NCT01957241|
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : October 8, 2013
Last Update Posted : April 16, 2014
|Condition or disease|
|Hepatocellular Carcinoma Esophageal Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||164 participants|
|Official Title:||Serum Biomarker Study for the Prognosis of Patients With Hepatocellular Carcinoma and Esophageal Cancer Undergoing Radiotherapy Using Multiplex Proximity Ligation Assay|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|Hepatocellular Carcinoma and Esophageal Cancer|
- BIOMARKER PANEL SELECTION AND MODELING [ Time Frame: 3 years ]All statistical analyses completed in this study are executed using the R statistical computing environment. To select the discrete set of biomarkers used to fit models of HCC or esophageal cancer diagnosis, we use the R distribution of the Prediction Analysis of Microarrays statistical technique, PAMR. Logistic regression models are fit using the generalized linear model function in R.
- SURVIVAL AND RT-RELATED TOXICITY ANALYSIS AND MODELING [ Time Frame: 3 years ]Survival data are fit to a right-censored model using the Survival function in the R statistical computing environment. Univariate and multivariate Cox proportional hazards models are fit onto survival data using the coxph function. Hazard ratios are calculated as the ratios of risk by the increase or decrease of 1 log2 PLA unit (2-fold increase or decrease in serum concentration of a biomarker). Lung or liver toxicity is graded by Common Toxicity Criteria version 3.0. Grade of toxicity is defined as the categorical variable and is correlated with the ratios of risk by the increase or decrease of 1 log2 PLA unit.
Biospecimen Retention: Samples With DNA
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): NCT01957241
|Contact: Jason Chia-Hsien Cheng, MD, PhD||886-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Jason Chia-Hsien Cheng, MD, PhD 886-23123456 ext 62842 firstname.lastname@example.org|
|Principal Investigator:||Jason Chia-Hsien Cheng, MD, PhD||Department of Oncology, National Taiwan University Hospital|