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NCT Number: NCT02973204

Circulating Tumor Cells and Tumor DNA in HCC and NET

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • one of the above mentioned diseases
  • planed surgery, RFA, Somatostatin Analogue, Sorafenib or Everolimus treatment
  • signed informed consent

Exclusion criteria

  • age below 18, concomitant invasive cancer (not skin cancer) and planed emigration of Denmark.

Treatment and study plan

Sorafenib

Drug

Other names: Nexavar, Anatomical Therapeutic Chemical Classification System L01XE05

Radiofrequency ablation (RFA) or surgery

Procedure

Intended curative surgery or RFA

Everolimus

Drug

Other names: Certican, Afinitor, Votubia, Anatomical Therapeutic Chemical Classification System L01XE10

Lanreotide

Drug

Or other somatostatin analogues (SSTA), eg. Sandostatin

Other names: Ipstyl, Sandostatin LAR, Octreotide

Primary outcomes

  1. Concordance between specific DNA mutations found in patient biopsies and plasma circulating tumor DNA

    Time frame: 2 months

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

Secondary outcomes

  1. Flow cytometry for detection and quantification of CTC in peripheral blood (absolute and relative counts)

    Time frame: 3 years

  2. Correlations between mutations found in circulating tumor DNA and amount of circulating tumor cells and treatment response according to RECIST criteria

    Time frame: up to 5 years

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

  3. Correlations between mutations found in circulating tumor DNA and amount of circulating tumor cells and survival

    Time frame: up to 5 years

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

  4. Correlations between mutations fund in circulating DNA and circulating tumor cells

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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