Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy

NCT02066974 | Unknown

• 1 other identifier: CMUH102-REC2-112
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients were presented with advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC or tumors causing portal vein thrombosis. With the development of novel radiotherapy (RT) technique, RT can be safely given to patients with larger tumor or portal vein thrombosis. However, RT could achieve a tumor response rate of approximately 50 %. Currently, there was a paucity of studies regarding a quantitative biomarker to predict tumor response or forecast the outcome in advance. To optimize the therapeutic index, there is a need to seek effective biomarkers for personal medicine because pretreatment AFP is not always useful as a surrogate marker in some of the patients. The present study is to investigate whether circulating tumor cell genome in peripheral blood can be used to predict RT response in HCC. We will use the blood sample from patients with locally advanced HCC receiving RT. By using next generation sequencing, We are going to explore the quantity and quality changes of DNAs and RNAs in the patient's serum or plasma. By this way, genomic expression in peripheral blood may play a key role in determining the optimal therapeutic strategies for HCC patients by predicting tumor response to RT.

Conditions

Circulating Neoplastic Cells; Adverse Effect of Radiation Therapy; Fatal Outcome

Keywords

hepatocellular carcinoma; genomic expression; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Response rate

  The correlation between response rate and circulating tumor cell genome

  one month

Secondary Outcomes (1)

• Overall survival, relapse-free survival

  two year

Study Arms (1)

Hepatoma, Circulating tumor genome

Hepatoma requiring radiotherapy

Genetic: hepatoma requiring radiotherapy

Interventions

hepatoma requiring radiotherapy GENETIC

hepatoma requiring radiotherapy

Hepatoma, Circulating tumor genome

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with advanced hepatoma requiring radiotherapy

You may qualify if:

• Patients with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE. A maximal tumor diameter \> 3.0 cm
• Age \> 20, and \< 80 years
• ECOG 0 or 1
• Life expectancy of at least 12 weeks
• Child-Pugh A
• Cancer of the Liver Italian Program (CLIP) score ≦ 3
• Pretreatment liver function test and renal function test:Total bilirubin \< 1.5 times the upper limit of normal (ULN), GOP/GPT ≦ 5 X of upper limit of normal range, Alkaline phosphatase ≦ 4X of ULN, Prothrombin time / partial prothrombin time \< 1.5 X of ULN, Serum Creatinine ≦ 1.0 x ULN
• Pretreatment blood count:Hemoglobulin ≧ 9 g/dl, Absolute neutrophil count ≧ 1500/mm3,Platelet count ≧ 100,000/mm3
• Subjects with at least one uni-dimensional or bi-dimensional measurable lesion and lesion must be measured by CT scan

You may not qualify if:

• Child-Pugh C
• CLIP score ≧ 4
• Patients with evidence of extrahepatic or metastatic disease
• Patients with evidence of massive ascites
• Patients receiving previous irradiation to liver

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 404, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fragmented DNA and RNA, Methylation

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Radiation Injuries; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Shang-Wen Chen, MD

  China Medical University Hosptal

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Radiation Oncology

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

TW (1)