DRUG
Circulating Tumor Cells and Tumor DNA in HCC and NET
Status
Completed
Phase
Not applicable
Enrollment
167
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
PROCEDURE
Radiofrequency ablation (RFA) or surgery
Intended curative surgery or RFA
DRUG
Everolimus
DRUG
Lanreotide
Or other somatostatin analogues (SSTA), eg. Sandostatin
Timeline
From registration to results.
First posted
Nov 25, 2016
Study start
Nov 2016
Primary completion
Jan 8, 2020
Study completion
Jan 8, 2020
Results posted
Not reported
Registry updated
Apr 28, 2021
Outcomes
What the study measures.
Primary outcomes
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
Flow cytometry for detection and quantification of CTC in peripheral blood (absolute and relative counts)
Time frame · 3 years
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
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
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Department of Hepatology and Gastroenterology
Aarhus, Aarhus C, Denmark
Publications
Results and literature.
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