An observational study in Prostatic Neoplasms, sponsored by Sormland County Council, Sweden. Status unknown at 1 site in Sweden. Open to male participants aged 18 Years to 125 Years. Per ClinicalTrials.gov, last updated 2019-09-24.
Sponsored by Sormland County Council, Sweden · Observational
Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients? Is it possible to understand the causal relationship between the occurrence of the tumor cells and the tumor DNA in the blood by reviewing the patient's medical records, including information about investigations, analytical reports or diagnoses? Can gene defects that may be useful in predicting the best treatment be detected by sequencing individual tumor cells or plasma from blood samples?
Prostate cancer is the most common form of cancer in men and the second most deadly. Today's diagnostic methods and treatments are therefore obviously not adequate. In this study we will evaluate a new diagnostic sampling and analysis method for prostate cancer, not try new treatments. The test sampling involves the rare tumor cells and tumor DNA found in the blood, and sequencing their DNA to determine which, if any, defective genes they contain that may explain the disease. There is currently no universally accepted diagnostic test of either tumor cells or tumor DNA in blood. We have access to new technology that one of us (CE) developed at the Karolinska Institute, which by all accounts can give access to the rare tumor cells in the blood so that we can sequence their DNA. In this study we want to try to see if it is possible in practical healthcare to apply the new technology for prostate cancer patients and if there are signs that it works equally well in the healthcare environment as in the laboratory.
Impact: If the sampling of tumor cells and tumor DNA from blood samples works within the healthcare system processes, it will be possible to understand the causal relationships behind their occurrence, and their gene defects, we can design follow-up studies that would take us closer to clinical use of the new technology to predict which treatment would be most effective and which treatment would produce the least side effects.
Ethical considerations: The risks of blood sampling are limited and known and can be managed within the healthcare system. Data is handled safely. The potential future benefit of a new cancer cell- and DNA-test is great.
The study is a collaboration between Region Sörmland, Karolinska Institutet and iCellate Medical AB. The data collection is expected to be completed in 2020 and the analyses in 2021.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sormland County Council, Sweden is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred to the urology clinic for investigation of a suspected urologic condition
Exclusion Criteria:
Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation
Diagnostic Test: IsoPic
Patients with diagnosed stage 3 prostate cancer
Diagnostic Test: IsoPic
Patients with diagnosed stage 4 prostate cancer
Diagnostic Test: IsoPic
Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition
Diagnostic Test: IsoPic
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
Single cell DNA sampling
Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?
Time frame: September 2019 to December 31st, 2020
Comparison of novel sampling results to established biomarkers
Is it possible to understand the causal link between the presence and amounts of tumor cells and tumor DNA in the blood by reviewing the patient's medical records, including information on investigations, analysis reports and diagnosis?
Time frame: September 2019 to December 31st, 2020
Single cell DNA sequencing
Can acquired gene defects that may predict treatment be detected by sequencing individual tumor cells, or break-down products, from blood samples?
Time frame: September 2019 to December 31st, 2020
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sormland County Council, Sweden