PLA for HCC and Esophageal ca Serum

NCT01957241 | Unknown

• 1 other identifier: 20110606IRC
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to quantify the biomarkers of pre-radiation therapy(RT), during-RT, and post-RT serum samples from hepatocellular carcinoma (HCC) and esophageal cancer patients undergoing definitive or neoadjuvant RT, and to correlate them with tumor response, patterns of failure, survival outcome, and RT-related lung or liver toxicity. The secondary goal of this study is to set up the PLA platform in our institute for future biomarker test.

Conditions

Hepatocellular Carcinoma; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• BIOMARKER PANEL SELECTION AND MODELING

  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.

  3 years

Secondary Outcomes (1)

• SURVIVAL AND RT-RELATED TOXICITY ANALYSIS AND MODELING

  3 years

Study Arms (1)

Hepatocellular Carcinoma and Esophageal Cancer

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We collected the pre-treatment and post-treatment serum samples of patients with hepatocellular carcinoma undergoing definitive radiotherapy and patients with esophageal cancer undergoing neoadjuvant chemoradiotherapy.

You may qualify if:

• Clinical diagnosis of locally advanced esophageal cancer or Hepatocellular Carcinoma, RT is indicated
• Informed consent signed

You may not qualify if:

• not completed RT

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We have collected the serum samples of patients before, during, and after RT with consent of two completed clinical trials and one active trial.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jason Chia-Hsien Cheng, MD, PhD

  Department of Oncology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Chia-Hsien Cheng, MD, PhD

CONTACT

886-23123456; jasoncheng@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 8, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

TW (1)