Circulating Tumor Cells and Tumor DNA in HCC and NET
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02973204|
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : October 12, 2018
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):
- Identify and isolate the CTC and investigate these for tumor-specific mutations.
- Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC.
- 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.
|Condition or disease||Intervention/treatment|
|Carcinoma, Hepatocellular Neuroendocrine Tumors||Drug: Sorafenib Procedure: Radiofrequency ablation (RFA) or surgery Drug: Everolimus Drug: Lanreotide|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||130 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Circulating Tumor Cells and Tumor DNA in HCC and NET - Patient-specific Biomarkers for Clinical Decision Support and Tailored Relapse Diagnostics|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
HCC patients referred for Sorafenib treatment
HCC curative treatment
HCC patient undergoing potential curative treatment, eg. radiofrequency ablation (RFA) or resection
Procedure: Radiofrequency ablation (RFA) or surgery
Intended curative surgery or RFA
Pancreatic NET patients referred for Everolimus treatment
Small intestinal or unknown primary NET patients referred for treatment with somatostatin analogues, eg. lanreotide and octreotide
Or other somatostatin analogues (SSTA), eg. Sandostatin
- 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
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973204
|Contact: Stine Karlsen, MDemail@example.com|
|Contact: Jens Kelsen, Consultantfirstname.lastname@example.org|
|Department of Hepatology and Gastroenterology||Recruiting|
|Aarhus, Aarhus C, Denmark, 8000|
|Contact: Stine Karlsen, MD, Phd Student +4522793193 email@example.com|
|Contact: Jens Kelsen, Consultant, PhD +4530562682 firstname.lastname@example.org|
|Principal Investigator: Stine Karlsen, MD, Phd student|
|Study Chair:||Jens Kelsen, Consultant||Department of Hepatology and Gastroenterology, Aarhus University Hospital|