Recruiting

Predictive Biomarker

Sponsor:

Peking Union Medical College Hospital

Code:

NCT02036216

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Hepatocellular Carcinoma

Study ID

NCT02036216

Start date

Jan, 2014

Status verified date

Jan, 2014

Completion date

Mar, 2016

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Hepatocellular Carcinoma

The mutation will be found in the DNA samples from the plasma and solid tumor tissues in the patients with HCC.

Primary outcome measure

  • To collect the DNA samples from the plasma, blood cells and solid tumor tissues in the patients with HCC. [ Time Frame: three months ]

Central Contacts and Locations

Central contacts

Locations

Stanford Genome Technology Center

Recruiting

Stanford, California, United States, 94304

Contacts

Principal Investigator:

Wenzhong Xiao, Dr

More Information

Sponsor

Peking Union Medical College Hospital

Last update posted

Jan 14, 2014

Last verified

Jan, 2014

Keywords

  • Hepatocellular Carcinoma;cell free tumor DNA; Mutation;

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Peking Union Medical College Hospital on 2014-01-14.