Measurement of Circulating Tumor Cells in Prostate Cancer (ICELLATEPC)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Sormland
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Eskilstuna, Sormland, Zweden, 631 88
- Mälarsjukhuset
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- patients diagnosed with prostate cancer of moderate risk planned for prostatectomy with lymph node removal, or
- patients diagnosed with prostate cancer stage 3, or
- patients with diagnosed prostate cancer stage 4, or
- patients with diagnosed benign inflammatory prostatitis or other benign urological condition constituting age-matched, cancer free, controls
Exclusion Criteria:
- Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)
- Patients with previous malignancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Localised prostate cancer
Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
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Stage 3 prostate cancer
Patients with diagnosed stage 3 prostate cancer
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
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Stage 4 prostate cancer
Patients with diagnosed stage 4 prostate cancer
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
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Healthy controls
Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition
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Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Single cell DNA sampling
Tijdsspanne: September 2019 to December 31st, 2020
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Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?
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September 2019 to December 31st, 2020
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Comparison of novel sampling results to established biomarkers
Tijdsspanne: September 2019 to December 31st, 2020
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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?
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September 2019 to December 31st, 2020
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Single cell DNA sequencing
Tijdsspanne: September 2019 to December 31st, 2020
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Can acquired gene defects that may predict treatment be detected by sequencing individual tumor cells, or break-down products, from blood samples?
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September 2019 to December 31st, 2020
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Evangelos Digkas, MD, PhD, Region Sörmland
Publicaties en nuttige links
Algemene publicaties
- Castro et al., Surgery Curr Res 2012, 2:3 http://dx.doi.org/10.4172/2161-1076.1000113
- Castro et al., J Integr Oncol 2018, 7:3 DOI: 10.4172/2329-6771.1000212
- Castro et al., Disease Markers Volume 2018, Article ID 4653109, 5 pages https://doi.org/10.1155/2018/4653109
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2019-02592
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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