An observational study in Carcinoma, Hepatocellular and Neuroendocrine Tumors, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University of Aarhus · Observational
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):
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.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's enrollment of 167 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
40 patients newly diagnosed NET patients referred for somatostatin analogue treatment for small intestinal NET or NET with unknown primary.
30 Pancreatic NET patients treated for known residual disease will be monitored for possible progression of disease and response to Everolimus 30 HCC patients supposed radically treated, either by RFA or liver resection, will be followed with regard to relapse.
30 HCC patients treated with Sorafenib monitored for treatment response
Exclusion Criteria:
HCC patients referred for Sorafenib treatment
Drug: Sorafenib
HCC patient undergoing potential curative treatment, eg. radiofrequency ablation (RFA) or resection
Procedure: Radiofrequency ablation (RFA) or surgery
Pancreatic NET patients referred for Everolimus treatment
Drug: Everolimus
Small intestinal or unknown primary NET patients referred for treatment with somatostatin analogues, eg. lanreotide and octreotide
Drug: Lanreotide
Also known as: Nexavar, Anatomical Therapeutic Chemical Classification System L01XE05
Intended curative surgery or RFA
Also known as: Certican, Afinitor, Votubia, Anatomical Therapeutic Chemical Classification System L01XE10
Or other somatostatin analogues (SSTA), eg. Sandostatin
Also known as: Ipstyl, Sandostatin LAR, Octreotide
Concordance between specific DNA mutations found in patient biopsies and plasma circulating tumor DNA
Methods: digital droplet PCR and targeted sequencing of blood samples and biopsies
Time frame: 2 months
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
Methods: digital droplet PCR and targeted sequencing of blood samples, and flowcytometry and cell separation of blood samples
Time frame: up to 5 years
Correlations between mutations found in circulating tumor DNA and amount of circulating tumor cells and survival
Methods: digital droplet PCR and targeted sequencing of blood samples, and flowcytometry and cell separation of blood samples
Time frame: up to 5 years
Correlations between mutations fund in circulating DNA and circulating tumor cells
Methods: digital droplet PCR and targeted sequencing of blood samples, and flowcytometry and cell separation of blood samples
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University of Aarhus