HematuriaNCT01563796
Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
An observational study of Hematuria and Dysuria, run by Medical Diagnostic Laboratories, LLC at 1 site in United States.
Trial summary
The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in the urine of patients suspected of having bladder cancer. The measurement of urine DEK protein, relative to an established cut-off, is correlated with the presence or absence of bladder cancer. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hematuria, Dysuria, Bladder Cancer
- How many people
- 1,115 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 15 Oct 2016
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients visiting urologist (primary care, referral, community, university or hospital).
Who may be able to join
- Patients who are at least twenty-five (25) years of age with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones.
Who cannot join
- Females who are pregnant (ascertained by history)
- Females who are menstruating or within three (3) days of their last menstruation
- Patients who have undergone invasive procedures of the urogenital tract in the past two (2) months
- Patients with a history of transitional cell carcinoma (TCC) of the urinary tract
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer
The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in the urine of patients suspected of having bladder cancer. The measurement of urine DEK protein, relative to an established cut-off, is correlated with the presence or absence of bladder cancer.
Read the detailed description
Sample Collection:
Urine samples used in the study will be collected immediately prior to the urological evaluation procedure and stored at -80 oC. Urine samples will be sent to sponsor and remain at -80o C until analysis.
Clinical Data Collection:
All subject and clinical information will be recorded on the form in section 9.3. Enrollment Checklist and Case Report Form (CRF). Information regarding the history of hematuria and urine cytology will be recorded. In addition, non-identifying information including age, sex, race, smoking history, alcohol consumption, occupational exposure to chemicals or dyes, history of urologic disorder or disease, history of irritative voiding symptoms, history of urinary tract infection, history of pelvic irradiation, and analgesic abuse will be recorded. The Investigators will also be asked to provide information from the subjects' medical records for up to one (1) year after their enrollment and sample collection. In particular, diagnosis of TCC, other malignant diseases, or non-malignant urogenital conditions will be provided.
- Conditions
- Hematuria, Dysuria, Bladder Cancer
- Keywords
- bladder cancer, TCC, urine, protein ELISA
- Medical subject headings
- Hematuria, Dysuria, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TCC positive | subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to have a bladder tumor confirmed by histopathology | |
| TCC negative | subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to NOT have a bladder tumor by histopathology or clinical observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histology
Measured: Up to 1 year after cystoscopy/biopsy
Secondary outcomes (2)
Cystoscopy
Measured: up to 3 months after collection
Cytology
Measured: up to 3 months after collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion1 Oct 2015
- Study completion15 Oct 2016
Why it stopped: Business decision made not to pursue malignant disease diagnostic devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HematuriaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Diagnostic Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Trama, PhD, Study director, Medical Diagnostic Laboratories, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563796
- Sponsor's protocol ID
- ONC04
- Status last verified
- Sep 2025
- First submitted
- 23 Mar 2012
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Datta A, Adelson ME, Mogilevkin Y, Mordechai E, Sidi AA, Trama JP. Oncoprotein DEK as a tissue and urinary biomarker for bladder cancer. BMC Cancer. 2011 Jun 10;11:234. doi: 10.1186/1471-2407-11-234.
PubMed 21663673
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer
- ClinicalTrials.gov ID
- NCT01563796
- Acronym / sponsor ID
- ONC04
- Conditions
- Hematuria, Dysuria, Bladder Cancer
- Keywords
- bladder cancer, TCC, urine, protein ELISA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision made not to pursue malignant disease diagnostic devices
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- Medical Diagnostic Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 27 Mar 2012 (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 objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in the urine of patients suspected of having bladder cancer. The measurement of urine DEK protein, relative to an established cut-off, is correlated with the presence or absence of bladder cancer.
Detailed description
Sample Collection:
Urine samples used in the study will be collected immediately prior to the urological evaluation procedure and stored at -80 oC. Urine samples will be sent to sponsor and remain at -80o C until analysis.
Clinical Data Collection:
All subject and clinical information will be recorded on the form in section 9.3. Enrollment Checklist and Case Report Form (CRF). Information regarding the history of hematuria and urine cytology will be recorded. In addition, non-identifying information including age, sex, race, smoking history, alcohol consumption, occupational exposure to chemicals or dyes, history of urologic disorder or disease, history of irritative voiding symptoms, history of urinary tract infection, history of pelvic irradiation, and analgesic abuse will be recorded. The Investigators will also be asked to provide information from the subjects' medical records for up to one (1) year after their enrollment and sample collection. In particular, diagnosis of TCC, other malignant diseases, or non-malignant urogenital conditions will be provided.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCC positive | – | –subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to have a bladder tumor confirmed by histopathology |
| TCC negative | – | –subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to NOT have a bladder tumor by histopathology or clinical observation. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients visiting urologist (primary care, referral, community, university or hospital).
Key inclusion criteria (1 listed)
- Patients who are at least twenty-five (25) years of age with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones.
Key exclusion criteria (4 listed)
- Females who are pregnant (ascertained by history)
- Females who are menstruating or within three (3) days of their last menstruation
- Patients who have undergone invasive procedures of the urogenital tract in the past two (2) months
- Patients with a history of transitional cell carcinoma (TCC) of the urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histology
Time frame: Up to 1 year after cystoscopy/biopsy
2 secondary outcomes
Cystoscopy
Time frame: up to 3 months after collection
Cytology
Time frame: up to 3 months after collection
Results and safety
The study was stopped early (reason given: Business decision made not to pursue malignant disease diagnostic devices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 21663673Datta A, Adelson ME, Mogilevkin Y, Mordechai E, Sidi AA, Trama JP. Oncoprotein DEK as a tissue and urinary biomarker for bladder cancer. BMC Cancer. 2011 Jun 10;11:234. doi: 10.1186/1471-2407-11-234.
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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.
Jason Trama, PhD study director
Medical Diagnostic Laboratories, LLC
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 Hematuria and Dysuria, run by Medical Diagnostic Laboratories, LLC at 1 site 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Sep 2025. 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 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?
The study was stopped early (reason given: Business decision made not to pursue malignant disease diagnostic devices). 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?
Histology (time frame: Up to 1 year after cystoscopy/biopsy). 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 NCT01563796, which also lists 1 linked publication.
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 26 Sep 2025.