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Measurement of Circulating Tumor Cells in Prostate Cancer (ICELLATEPC)

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: NCT04101305
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
Karolinska Institutet
iCellate Medical
Information provided by (Responsible Party):
Christer Ericsson, Sormland County Council, Sweden

Brief Summary:
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?

Condition or disease Intervention/treatment
Prostatic Neoplasms Diagnostic Test: IsoPic

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Circulating Tumor Cells in Prostate Cancer
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Localised prostate cancer
Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation
Diagnostic Test: IsoPic
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Stage 3 prostate cancer
Patients with diagnosed stage 3 prostate cancer
Diagnostic Test: IsoPic
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Stage 4 prostate cancer
Patients with diagnosed stage 4 prostate cancer
Diagnostic Test: IsoPic
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Healthy controls
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




Primary Outcome Measures :
  1. Single cell DNA sampling [ Time Frame: September 2019 to December 31st, 2020 ]
    Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?


Secondary Outcome Measures :
  1. Comparison of novel sampling results to established biomarkers [ Time Frame: September 2019 to December 31st, 2020 ]
    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?

  2. Single cell DNA sequencing [ Time Frame: September 2019 to December 31st, 2020 ]
    Can acquired gene defects that may predict treatment be detected by sequencing individual tumor cells, or break-down products, from blood samples?


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender identity
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the urology clinic for investigation of a suspected urologic condition
Criteria

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

Information from the National Library of Medicine

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): NCT04101305


Contacts
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Contact: Ninos Oussi, MD +4616103000 ninos.oussi@ki.se
Contact: Evangelos Digkas, MD, PhD +46728598648 Evangelos.Digkas@regionsormland.se

Locations
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Sweden
Malarsjukhuset
Eskilstuna, Sormland, Sweden, 631 88
Contact: Evangelos Digkas, MD, PhD    +46728598648    Evangelos.Digkas@regionsormland.se   
Contact: Ninos Oussi, MD    +46016103000    ninos.oussi@ki.se   
Principal Investigator: Christer Ericsson, PhD         
Sponsors and Collaborators
Sormland County Council, Sweden
Karolinska Institutet
iCellate Medical
Investigators
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Study Director: Evangelos Digkas, MD, PhD Region Sormland
Additional Information:
Publications:
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

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Responsible Party: Christer Ericsson, Senior scientist, Sormland County Council, Sweden
ClinicalTrials.gov Identifier: NCT04101305    
Other Study ID Numbers: 2019-02592
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christer Ericsson, Sormland County Council, Sweden:
Prostate cancer, biomarker
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes