Kidney CancerNCT02143492
Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC
An observational study of Kidney Cancer and Renal Cell Carcinoma, run by Argos Therapeutics at 5 sites in United States.
Trial summary
Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor specimens that would normally be discarded after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma
- How many people
- 11 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2013to Jul 2015
- 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: Subject with advanced renal cell carcinoma (kidney cancer)
Who may be able to join
- 1. Age ≥ 18 years
- 2. Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to Appendix A)
- 3. Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy
- 4. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of tumor specimen collection prior to enrollment
Who cannot join
- 1. Evidence of brain metastases prior to nephrectomy
- 2. Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids, for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
- 3. History of HIV infection, or history of chronic infection with Hepatitis B or Hepatitis C
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Englewood, Colorado, 80113
Study site
Marietta, Georgia, 30060
Study site
Rock Hill, North Carolina, 29732
Study site
Tacoma, Washington, 98405
Study site
Woodbury, Minnesota, 55125
About this study
Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor specimens that would normally be discarded after surgery.
Read the detailed description
The purpose of this non-treatment, non-interventional protocol is to collect, preserve, and store excess tumor specimens, which would otherwise be discarded, following routine nephrectomy for subjects with advanced renal cell carcinoma (RCC). The collected tumor specimen will be preserved under current Good Manufacturing Practice conditions and will not be used for any other research or therapeutic purpose without a separate consent from the subject, specific to the intended use on a separate Institutional Review Board or Institutional Ethics Committee approved Argos sponsored study.
Following routine nephrectomy (partial or cytoreductive) as indicated for subjects with advanced RCC, small samples of the excised tumor will be sectioned and placed into an RNA preservative solution as supplied by the sponsor. After collection, this preserved tumor specimen will be shipped to a repository operating under current Good Manufacturing Practice conditions. The tumor specimen will be stored for no longer than five years unless subsequent consent is obtained for extended storage or other use.
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Specimen
Tumor specimen collection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neal Shore, MD, FACP, Principal investigator, Carolina Urologic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143492
- Sponsor's protocol ID
- AGS-NTS-020
- Status last verified
- Jan 2017
- First submitted
- 30 Apr 2014
- Last updated
- 24 Jan 2017
- 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 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC
- ClinicalTrials.gov ID
- NCT02143492
- Acronym / sponsor ID
- AGS-NTS-020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 May 2014 (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.
Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor specimens that would normally be discarded after surgery.
Detailed description
The purpose of this non-treatment, non-interventional protocol is to collect, preserve, and store excess tumor specimens, which would otherwise be discarded, following routine nephrectomy for subjects with advanced renal cell carcinoma (RCC). The collected tumor specimen will be preserved under current Good Manufacturing Practice conditions and will not be used for any other research or therapeutic purpose without a separate consent from the subject, specific to the intended use on a separate Institutional Review Board or Institutional Ethics Committee approved Argos sponsored study.
Following routine nephrectomy (partial or cytoreductive) as indicated for subjects with advanced RCC, small samples of the excised tumor will be sectioned and placed into an RNA preservative solution as supplied by the sponsor. After collection, this preserved tumor specimen will be shipped to a repository operating under current Good Manufacturing Practice conditions. The tumor specimen will be stored for no longer than five years unless subsequent consent is obtained for extended storage or other use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with advanced renal cell carcinoma (kidney cancer)
Key inclusion criteria (4 listed)
- 1. Age ≥ 18 years
- 2. Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to Appendix A)
- 3. Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy
- 4. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of tumor specimen collection prior to enrollment
Key exclusion criteria (3 listed)
- 1. Evidence of brain metastases prior to nephrectomy
- 2. Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids, for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
- 3. History of HIV infection, or history of chronic infection with Hepatitis B or Hepatitis C
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
Tumor Specimen
Time frame: 5 years
Tumor specimen collection
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 24 Jan 2017.
- 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.
Neal Shore, MD, FACP principal investigator
Carolina Urologic Research Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer and Renal Cell Carcinoma, run by Argos Therapeutics 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 4 inclusion and 3 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 24 Jan 2017. 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?
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?
Tumor Specimen (time frame: 5 years). 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 24 Jan 2017.