NCT02973204

Circulating Tumor Cells and Tumor DNA in HCC and NET

Circulating Tumor Cells and Tumor DNA in HCC and NET - Patient-specific Biomarkers for Clinical Decision Support and Tailored Relapse Diagnostics

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 167 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background Treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies. Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the analysis of the CTC. The investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support. Purpose and method In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and digital polymerase chain reaction (PCR): 1. Identify and isolate the CTC and investigate these for tumor-specific mutations. 2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC. 3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies. The results are compared with the clinical data on disease course, including the effect of treatment and survival. Subjects 40 Patients with small intestinal/unknown primary NET before treatment with somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30 patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years. Perspectives In several cancer types molecular diagnostics have had significant influence in treatment and control strategy. The goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. The study will bring new knowledge to this growing field of research.

Conditions

• Carcinoma, Hepatocellular
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Sorafenib
PROCEDURE	Radiofrequency ablation (RFA) or surgery	Intended curative surgery or RFA
DRUG	Everolimus
DRUG	Lanreotide	Or other somatostatin analogues (SSTA), eg. Sandostatin

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-01-08
• Completion: 2020-01-08
• First posted: 2016-11-25
• Last updated: 2021-04-28

Locations

1 site across 1 country: Denmark