Hepatocellular Carcinoma Clinical Trial
Official title:
Detected the Valuable Characteristic Changes Both in Circulating Cell-free DNA and Primary Tumor in the Patients With Hepatocelluar Carcinoma.
Circulating free cell DNA (cfDNA) is extracellular fragmentation of nucleic acids that occurs both in plasma and serum. This kind of DNA which derived from the apoptotic/necrotic cells or the lysis of circulating tumor cells (CTCs) can be detectedin the patients with a variety of diseases. Emerging evidence suggests that cfDNA from patients exhibits characteristicchanges of tumors, suchas mutations, insertions/deletions, methylations,microsatellite aberrations, and copy number variations, etc. All of these reveal a visible difference between the benign conditions, and thus may be useful in the diagnosis of cancer, identification of targeted therapy, monitor responses to treatments, and early detection of relapse. The purpose for this study is to explore these characteristic changes in the patients withhepatocellular carcinoma (HCC) and expect to guide targeted therapy and identify non-invasive biomarkers of cancer diagnosis and prognosis which can be easily isolated from the circulation.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 2016 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Age=18years and =80 years; Histologically and cytologically proven Hepatocellular carcinoma Child-Pugh:child A-B Adequate hematological, renal, cardiac and pulmonary functions Tumor in any segment of liver Exclusion Criteria: Uncontrolled systemic disease Reject the surgical treatment Metastatic carcinoma Child-Pugh:child C |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
China | Department of liver surgery; Peking Union Medical College Hospital; | Beijing | Beijing |
United States | Stanford Genome Technology Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Stanford University |
United States, China,
Chen K, Zhang H, Zhang LN, Ju SQ, Qi J, Huang DF, Li F, Wei Q, Zhang J. Value of circulating cell-free DNA in diagnosis of hepatocelluar carcinoma. World J Gastroenterol. 2013 May 28;19(20):3143-9. doi: 10.3748/wjg.v19.i20.3143. — View Citation
Gall TM, Frampton AE, Krell J, Habib NA, Castellano L, Stebbing J, Jiao LR. Cell-free DNA for the detection of pancreatic, liver and upper gastrointestinal cancers: has progress been made? Future Oncol. 2013 Dec;9(12):1861-9. doi: 10.2217/fon.13.152. Review. — View Citation
Shen P, Wang W, Chi AK, Fan Y, Davis RW, Scharfe C. Multiplex target capture with double-stranded DNA probes. Genome Med. 2013 May 29;5(5):50. doi: 10.1186/gm454. eCollection 2013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To collect the DNA samples from the plasma, blood cells and solid tumor tissues in the patients with HCC. | In the first three months in this study, we will collect 5 samples from the plasma, blood cells and primary tumor lesions in the patients with HCC in three stages including preoperative, postoperative (2 weeks) and postoperative (1 month). It is better for us to find the characteristic changes when we make a detailed comparison between the samples in these period. These samples include 5ml plasma, 2ml blood cells without plasma and at least 10mg solid tumor tissues. | three months | No |
Secondary | Investigate the value characteristic changes from the DNA samples. | We will prepare the DNA samples from the plasma, blood cells and primary tumor lesions in the patients with HCC in Stanford Genome Technology Center. And then, we will finish DNA sequence in both of them. The DNA sequence which detect from the blood cells will be a normal standard, and thus will be compared with the DNA sequence detect in the samples of plasma and tumor tissues. In this way, we expect to find the common mutations in cfDNA and primary tumor lesions. | three months | No |
Secondary | Date analysis | Date analysis will help us to find the changes which have the highest probability in DNA sequence. After that, we will screen these characteristic changes and confirm the sensitive and special mutations which can help us to diagnose the HCC in early phase. | two months | No |
Secondary | Evaluate the sensitivity and specificity with these changes in HCC | After we find these valuable characteristic changes in HCC, 50 samples will be detected within these changes. On the basis of the deepen date analysis, we will evaluate the sensitivity and specificity with these changes in HCC. | four months | No |
Secondary | Early diagnosis, treatment monitoring and prognosis evaluation. | After we complete the evaluation and determine which genetic changes can be used, we will choose 100 patients with HCC and 50 patients who have accepted the surgery treatment in this trial phase. The first 100 patients will be detected these changes before the operation. After that, we expect to establish an evaluation system for early diagnosis in HCC. The postoperative patients will accept the cfDNA detection in the same way with the purpose of estimating the recurrence of the tumor | twelve months | No |
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