Cellular Diagnosis, Prostate CancerNCT02928640
ClariCore Optical Biopsy System Used in TRUS (Trans-Rectal Ultrasound)-Guided Prostrate Biopsy
A study testing ClariCore System in people with Cellular Diagnosis, Prostate Cancer, run by Precision Biopsy, Inc. at 5 sites in United States.
Trial summary
The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System. Read more about this study
- Who is it for?
- Ages 22 years and older, men only
- Conditions the study is for
- Cellular Diagnosis, Prostate Cancer
- What is being tested?
- ClariCore System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2016to Dec 2020
- Phase
- Interventional
- 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 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
- Prostrate volume ≥ 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate MRI
- Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
Who cannot join
- Contraindications to TRUS prostrate biopsy
- Acute painful perianal disorder
- Surgical absence of a rectum or the presence of a rectal fistula
- Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only)
- ---Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI
- Previous prostrate surgeries
Show all 21Show fewer
- Prior pelvic irradiation
- Active inflammatory bowel disease within the last 6 months
- Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g., significant cardiovascular conditions or allergies)
- Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
- Bladder cancer (current or prior)
- Symptomatic acute prostatitis
- Actively taking blood thinning agents (with the exception of low dose aspirin [81 mg] Plavix, Coumadin, etc.) or severe comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g., coagulopathy
- Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
- Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostrate)
- Neo-adjuvant hormonal therapy
- Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
- Patient has a compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
- Patient is not likely to comply with the follow-up evaluation schedule
- Patient is participating in a clinical trial of another investigational drug or device
- Patient is mentally incompetent or a prisoner
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Brady Urological Institute- The Johns Hopkins Hospital
Baltimore, Maryland, 21287
The Urology Center of Colorado
Denver, Colorado, 80211
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Comprehensive Urology
Royal Oak, Michigan, 48073
Associated Professionals of New York, PLLC
Syracuse, New York, 13210
About this study
Official title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing TRUS-Guided Prostrate Biopsy With or Without MR Fusion For Prostrate Tissue Classification Algorithm Development
The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.
Read the detailed description
The purpose of this study is to collect information on prostrate tissue biopsies using the ClariCore System. The ClariCore system is designed to improve how the tissue samples are being collected from the prostrate by using light sensors (fiber optics) that can see changes in the tissue. Researchers will study the data collected from the light sensor (optical readings) to develop a method (like a mathematical equation) that can be used to tell the difference between normal and cancerous prostrate tissue during the biopsy. What the researchers are hoping to learn from this study is if a light guided biopsy procedure can improve the accuracy of prostrate biopsy sampling.
- Conditions
- Cellular Diagnosis, Prostate Cancer
- Being tested
- ClariCore System
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariCore SystemDevice
Also called ClariCore Optical Biopsy System
Data collection to build the prostrate tissue classification algorithm.
| Study group | Role | What they receive |
|---|---|---|
| ClariCore System | Experimental | ClairCore System study designed for data collection to build the prostrate tissue classification algorithm. Receives: Device: ClariCore System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness
Correlate histopathology of tissue biopsy core samples with corresponding spectral data obtained in vivo for algorithm training at time of procedure.
Measured: Ath the time of procedure
Secondary outcomes (2)
Assessment of Pain
Pain shall be reported based on the patient-reported level of pain during the ClariCore System procedure and at 7 and 30 days post-procedure as measured on a 10 point numerical rating scale (NRS).
Measured: Up to 30 days post-procedure
Incidence and frequency of adverse events
The secondary safety endpoint is the incidence and frequency of all Adverse Event's (both related and unrelated to the ClariCore System) reported during the study.
Measured: Up to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellular Diagnosis, Prostate CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Biopsy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sierra Yearly, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928640
- Sponsor's protocol ID
- CIP-1010
- Status last verified
- Feb 2019
- First submitted
- 4 Oct 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing TRUS-Guided Prostrate Biopsy With or Without MR Fusion For Prostrate Tissue Classification Algorithm Development
- ClinicalTrials.gov ID
- NCT02928640
- Acronym / sponsor ID
- CIP-1010
- Conditions
- Cellular Diagnosis, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Precision Biopsy, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- 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.
The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.
Detailed description
The purpose of this study is to collect information on prostrate tissue biopsies using the ClariCore System. The ClariCore system is designed to improve how the tissue samples are being collected from the prostrate by using light sensors (fiber optics) that can see changes in the tissue. Researchers will study the data collected from the light sensor (optical readings) to develop a method (like a mathematical equation) that can be used to tell the difference between normal and cancerous prostrate tissue during the biopsy. What the researchers are hoping to learn from this study is if a light guided biopsy procedure can improve the accuracy of prostrate biopsy sampling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClariCore System | Experimental | Device: ClariCore SystemClairCore System study designed for data collection to build the prostrate tissue classification algorithm. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
- Prostrate volume ≥ 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate MRI
- Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
Key exclusion criteria (21 listed)
- Contraindications to TRUS prostrate biopsy
- Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only)
- ---Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI
- Previous prostrate surgeries
- Prior pelvic irradiation
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 |
|---|---|---|
| ClariCore SystemAlso: ClariCore Optical Biopsy SystemData collection to build the prostrate tissue classification algorithm. | Device | ClariCore System |
Primary outcome
Primary Effectiveness
Time frame: Ath the time of procedure
Correlate histopathology of tissue biopsy core samples with corresponding spectral data obtained in vivo for algorithm training at time of procedure.
2 secondary outcomes
Assessment of Pain
Time frame: Up to 30 days post-procedure
Incidence and frequency of adverse events
Time frame: Up to 30 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Sierra Yearly study director
Sponsor GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClariCore System in people with Cellular Diagnosis, Prostate Cancer, run by Precision Biopsy, Inc. at 5 sites in United States.
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 3 inclusion and 21 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness (time frame: Ath the time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.