Hepatocellular CarcinomaNCT01957241
PLA for HCC and Esophageal ca Serum
An observational study of Hepatocellular Carcinoma and Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma, Esophageal Cancer
- How many people
- 164 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of locally advanced esophageal cancer or Hepatocellular Carcinoma, RT is indicated
- Informed consent signed
Who cannot join
- not completed RT
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jason Chia-Hsien Cheng, MD, PhD, 886-23123456 ext. 62842, jasoncheng@ntu.edu.tw
About this study
Official title: Serum Biomarker Study for the Prognosis of Patients With Hepatocellular Carcinoma and Esophageal Cancer Undergoing Radiotherapy Using Multiplex Proximity Ligation Assay
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.
Read the 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
- Medical subject headings
- Carcinoma, Hepatocellular, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular Carcinoma and Esophageal Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
SURVIVAL AND RT-RELATED TOXICITY ANALYSIS AND MODELING
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Chia-Hsien Cheng, MD, PhD, Principal investigator, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957241
- Sponsor's protocol ID
- 20110606IRC
- Status last verified
- Apr 2014
- First submitted
- 24 Sep 2013
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Biomarker Study for the Prognosis of Patients With Hepatocellular Carcinoma and Esophageal Cancer Undergoing Radiotherapy Using Multiplex Proximity Ligation Assay
- ClinicalTrials.gov ID
- NCT01957241
- Acronym / sponsor ID
- 20110606IRC
- Conditions
- Hepatocellular Carcinoma, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular Carcinoma and Esophageal Cancer | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of locally advanced esophageal cancer or Hepatocellular Carcinoma, RT is indicated
- Informed consent signed
Key exclusion criteria (1 listed)
- not completed RT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
SURVIVAL AND RT-RELATED TOXICITY ANALYSIS AND MODELING
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Chia-Hsien Cheng, MD, PhD principal investigator
Department of Oncology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Chia-Hsien Cheng, MD, PhD (886-23123456 ext. 62842, jasoncheng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIOMARKER PANEL SELECTION AND MODELING (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.