Prostatic NeoplasmsICELLATEPCNCT04101305
Measurement of Circulating Tumor Cells in Prostate Cancer
An observational study of Prostatic Neoplasms, run by Sormland County Council, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 125 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- IsoPic
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the urology clinic for investigation of a suspected urologic condition
Who may be able to join
- 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
Who cannot join
- Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)
- Patients with previous malignancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Malarsjukhuset
Eskilstuna, Sormland, 631 88
Evangelos Digkas, MD, PhD, +46728598648, Evangelos.Digkas@regionsormland.se
Ninos Oussi, MD, +46016103000, ninos.oussi@ki.se
About this study
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?
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- IsoPic
- Keywords
- Prostate cancer, biomarker
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoPicDiagnostic test
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
| Study group | Role | What they receive |
|---|---|---|
| Localised prostate cancer | Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation Receives: Diagnostic Test: IsoPic | |
| Stage 3 prostate cancer | Patients with diagnosed stage 3 prostate cancer Receives: Diagnostic Test: IsoPic | |
| Stage 4 prostate cancer | Patients with diagnosed stage 4 prostate cancer Receives: Diagnostic Test: IsoPic | |
| Healthy controls | Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition Receives: Diagnostic Test: IsoPic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single cell DNA sampling
Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?
Measured: September 2019 to December 31st, 2020
Secondary outcomes (2)
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?
Measured: 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?
Measured: September 2019 to December 31st, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, iCellate Medical
- Responsible party
- Principal investigator, Christer Ericsson, Sormland County Council, Sweden
- Investigators
- Evangelos Digkas, MD, PhD, Study director, Region Sormland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101305
- Sponsor's protocol ID
- 2019-02592
- Other IDs
- 2019
- Acronym
- ICELLATEPC
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Circulating Tumor Cells in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04101305
- Acronym / sponsor ID
- ICELLATEPC / 2019-02592
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate cancer, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, iCellate Medical
- Study start
- Sep 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Localised prostate cancer | – | Diagnostic Test: IsoPicPatients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation |
| Stage 3 prostate cancer | – | Diagnostic Test: IsoPicPatients with diagnosed stage 3 prostate cancer |
| Stage 4 prostate cancer | – | Diagnostic Test: IsoPicPatients with diagnosed stage 4 prostate cancer |
| Healthy controls | – | Diagnostic Test: IsoPicAge-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the urology clinic for investigation of a suspected urologic condition
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)
- Patients with previous malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoPicBiomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing | Diagnostic test | Healthy controls, Localised prostate cancer, Stage 3 prostate cancer, Stage 4 prostate cancer |
Primary outcome
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?
2 secondary outcomes
Comparison of novel sampling results to established biomarkers
Time frame: September 2019 to December 31st, 2020
Single cell DNA sequencing
Time frame: September 2019 to December 31st, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- BackgroundCastro et al., Surgery Curr Res 2012, 2:3 http://dx.doi.org/10.4172/2161-1076.1000113
- BackgroundCastro et al., J Integr Oncol 2018, 7:3 DOI: 10.4172/2329-6771.1000212
- BackgroundCastro et al., Disease Markers Volume 2018, Article ID 4653109, 5 pages https://doi.org/10.1155/2018/4653109
- Government agency supervised clinical tumor cell and tumor DNA testing laboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos Digkas, MD, PhD study director
Region Sormland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Sormland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ninos Oussi, MD (+4616103000, ninos.oussi@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single cell DNA sampling (time frame: September 2019 to December 31st, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101305, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.