Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Neuroendocrine Tumors

Neoplastic Cells, Circulating

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasm Metastasis

Neoplastic Processes

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Infective Agents

Everolimus

Somatostatin

Octreotide

Sorafenib

Lanreotide

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Hormonal

HCC patients referred for Sorafenib treatment

HCC patient undergoing potential curative treatment, eg. radiofrequency ablation (RFA) or resection

Pancreatic NET patients referred for Everolimus treatment

Small intestinal or unknown primary NET patients referred for treatment with somatostatin analogues, eg. lanreotide and octreotide

Radiofrequency ablation (RFA) or surgery

Or other somatostatin analogues (SSTA), eg. Sandostatin

Jens Kelsen, Consultant

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.

Blood samples and biopsies when available.

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

Methods: digital droplet PCR and targeted sequencing of blood samples and biopsies

Methods: digital droplet PCR and targeted sequencing of blood samples, and flowcytometry and cell separation of blood samples

Aarhus University Hospital

University of Aarhus

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Circulating Tumor Cells and Tumor DNA in HCC and NET	NCT02973204	Carcinoma, Hepa... Neuroendocrine ...	Sorafenib Radiofrequency ... Everolimus Lanreotide	18 Years -	University of Aarhus
Circulating Tumor Cells and Tumor DNA in HCC and NET	NCT02973204	Carcinoma, Hepa... Neuroendocrine ...	Sorafenib Radiofrequency ... Everolimus Lanreotide	18 Years -	University of Aarhus
Circulating Tumor Cells and Tumor DNA in HCC and NET	NCT02973204	Carcinoma, Hepa... Neuroendocrine ...	Sorafenib Radiofrequency ... Everolimus Lanreotide	18 Years -	University of Aarhus

Spots Global Cancer Trial Database for radiofrequency ablation (rfa) or surgery