Measurement of Circulating Tumor Cells in Prostate Cancer (ICELLATEPC)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Sormland
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Eskilstuna, Sormland, Suécia, 631 88
- Mälarsjukhuset
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Single cell DNA sampling
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comparison of novel sampling results to established biomarkers
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Evangelos Digkas, MD, PhD, Region Sörmland
Publicações e links úteis
Publicações Gerais
- 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2019-02592
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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