PLA for HCC and Esophageal ca Serum

NCT ID: NCT01957241

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

There have been many biomarkers, such as angiogenesis factors and cytokines, related to cancer progression or microenvironment interaction. However, the commonly used enzyme-linked immunosorbent assay (ELISA) requires the certain volume of each sample for specific antigen or antibody. It may not be practically efficient to test a broad spectrum of biomarkers with limited volumes of serum from cancer patients. Proximity ligation assay (PLA), an established concept and platform requiring very little sample volume to quantitatively detect a variety of biomarkers, is being developed with multiplex versions of improved sensitivity and dynamic range by the Stanford group. From the three completed trials ("In vivo/vitro radiation-induced liver disease in HBV carrier（9261700196）", "Bystander effect study of radiation-induced viral hepatitis B reactivation（9261700196）", and "Pre- and post-chemoradiation blood RNA-microarray analysis to predict response and outcome of locally advanced esophageal squamous cell carcinoma（200805061R）") and one ongoing trial ("A phase I dose escalation trial of conformal hypofractionated radiation therapy for patients with hepatitis B virus-related Child A cirrhosis and hepatocellular carcinoma（200906051R）"), we have 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. Altered patterns of failure for post-radiotherapy hepatocellular carcinoma, especially intrahepatic and extrahepatic metastasis, and treatment response for post-chemoradiotherapy esophageal cancer upon esophagectomy, demands the effective biomarkers for the early prediction and appropriate management. The limited sample volumes form the obstacle of testing adequate number of biomarkers by ELISA. In this study we plan to collaborate with the Stanford group, to send and process these samples (100 μL each) to measure the dynamic changes of up to 56 or more biomarkers. We try to find the potential biomarkers correlating with treatment responses and patterns of failure for the future clinical practice, and wish to set up this viable PLA platform in our institute through this collaboration.

Conditions

Hepatocellular Carcinoma; Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatocellular Carcinoma and Esophageal Cancer

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• not completed RT

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Chia-Hsien Cheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jason Chia-Hsien Cheng, MD, PhD

Role: CONTACT

jasoncheng@ntu.edu.tw

886-23123456 ext. 62842

Facility Contacts

Jason Chia-Hsien Cheng, MD, PhD

Role: primary

jasoncheng@ntu.edu.tw

886-23123456 ext. 62842

Other Identifiers

20110606IRC

Identifier Type: -

Identifier Source: org_study_id