Renal Cell CarcinomaNCT02923284
NANOTECH RCC Biomarkers
An observational study of Renal Cell Carcinoma and Renal Cell Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Renal Cell Cancer
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 2 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are 18 years of age and older and undergoing planned surgical procedure for removal of an imaged renal mass will be consented in the Center for Preoperative Assessment and Planning (CPAP), the holding area on the day of surgery, and the holding area of radiology. A urine sample will be collected from subject following informed consent. Additionally, discarded urine samples will be collected from the BJH Chemistry Labs from patients admitted for surgery for non-kidney cancer as a comparator group.
Who may be able to join
- Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),
Who cannot join
- Age <18 years and prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University St Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility
The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.
- Conditions
- Renal Cell Carcinoma, Renal Cell Cancer
- Medical subject headings
- Carcinoma, Renal Cell
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 |
|---|---|---|
| Imaged renal mass cohort | Subjects undergoing surgery for an kidney tumor identified radiologically. | |
| control cohort | Subjects undergoing surgery for any kind of cancer other than kidney. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine AQP1
Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
Measured: 28 days
PLIN2 concentration
Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startAug 2016
- Primary completion2 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeremiah Morrissey, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923284
- Sponsor's protocol ID
- 201601082
- Other IDs
- 5R01CA141521
- Status last verified
- May 2020
- First submitted
- 7 Sep 2016
- Last updated
- 7 May 2020
- 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 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility
- ClinicalTrials.gov ID
- NCT02923284
- Acronym / sponsor ID
- 201601082
- Conditions
- Renal Cell Carcinoma, Renal Cell Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2016
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 4 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 incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaged renal mass cohort | – | –Subjects undergoing surgery for an kidney tumor identified radiologically. |
| control cohort | – | –Subjects undergoing surgery for any kind of cancer other than kidney. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are 18 years of age and older and undergoing planned surgical procedure for removal of an imaged renal mass will be consented in the Center for Preoperative Assessment and Planning (CPAP), the holding area on the day of surgery, and the holding area of radiology. A urine sample will be collected from subject following informed consent. Additionally, discarded urine samples will be collected from the BJH Chemistry Labs from patients admitted for surgery for non-kidney cancer as a comparator group.
Key inclusion criteria (1 listed)
- Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),
Key exclusion criteria (1 listed)
- Age <18 years and prisoners.
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
Urine AQP1
Time frame: 28 days
Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
PLIN2 concentration
Time frame: 28 days
Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- 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.
Jeremiah Morrissey, PhD principal investigator
Washington University School of Medicine
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 Renal Cell Carcinoma and Renal Cell Cancer, run by Washington University School of Medicine 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 1 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: finished, as of the sponsor's last update on 7 May 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urine AQP1 (time frame: 28 days). The study lists 2 primary outcomes in all. 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 7 May 2020.