Metastatic Renal Cell CarcinomaNCT02026960
RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
A study testing RNA extraction and amplification from biopsy specimens in people with Metastatic Renal Cell Carcinoma and Genitourinary Cancer (Bladder, Prostate or Testicular), run by Duke University at 1 site in United States.
Trial summary
The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Genitourinary Cancer (Bladder, Prostate or Testicular)
- What is being tested?
- RNA extraction and amplification from biopsy specimens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 7 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:
- 18 years of age or older.
- Suspected RCC, in the opinion of the investigator
- Availability of either:
- Nephrectomy or other surgically removed tissue (Stage I); or,
- Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).
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- ≥5 biopsy specimens available from BRPC.
- Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
- Not currently being treated with systemic therapy.
- 18 years of age or older
- Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
- Availability of surgically removed tissue or biopsy tissue.
- At least 2 biopsy specimens available from BRPC
- Not currently being treated with systemic therapy.
Who cannot join
- Tumor tissue is committed to other use or inadequate for RNA analysis.
- Insufficient tissue is collected in the BRPC.
- Expansion Cohort for Genitourinary Cancers:
- Tumor tissue is committed to other use or inadequate for RNA analysis.
- Insufficient tissue is collected in the BRPC.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.
- Being tested
- RNA extraction and amplification from biopsy specimens
- Medical subject headings
- Carcinoma, Renal Cell, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA extraction and amplification from biopsy specimensDevice
| Study group | Role | What they receive |
|---|---|---|
| Renal Cell Carcinoma Tumor Tissue | Experimental | Not described Receives: Device: RNA extraction and amplification from biopsy specimens |
| Genitourinary tumor tissue (Expansion cohort) | Experimental | Bladder, prostate or testicular cancer Receives: Device: RNA extraction and amplification from biopsy specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate for tumor RNA isolation and amplification
To Determine the success rate for tumor RNA isolation and amplification create a minimum of 10 doses of AGS-003, as defined by a minimum concentration of ≥84 µg/µL in typically greater than 150 µL final volume RNA. (Tissue obtained at time of surgery or biopsy depending on stage)
Measured: At time of surgery or during biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completion7 Sep 2017
Why it stopped: The sponsor's clinical program for the agent used in this study was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Argos Therapeutics
- Responsible party
- Sponsor
- Investigators
- Michael Harrison, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026960
- Sponsor's protocol ID
- Pro00047147
- Status last verified
- Dec 2018
- First submitted
- 2 Jan 2014
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
- ClinicalTrials.gov ID
- NCT02026960
- Acronym / sponsor ID
- Pro00047147
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor's clinical program for the agent used in this study was discontinued.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Argos Therapeutics
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 3 Jan 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.
The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Cell Carcinoma Tumor Tissue | Experimental | Device: RNA extraction and amplification from biopsy specimens |
| Genitourinary tumor tissue (Expansion cohort) | Experimental | Device: RNA extraction and amplification from biopsy specimensBladder, prostate or testicular cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:
- 18 years of age or older.
- Suspected RCC, in the opinion of the investigator
- Availability of either:
- ≥5 biopsy specimens available from BRPC.
Key exclusion criteria (5 listed)
- Tumor tissue is committed to other use or inadequate for RNA analysis.
- Insufficient tissue is collected in the BRPC.
- Tumor tissue is committed to other use or inadequate for RNA analysis.
- Insufficient tissue is collected in the BRPC.
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 |
|---|---|---|
| RNA extraction and amplification from biopsy specimens | Device | Genitourinary tumor tissue (Expansion cohort), Renal Cell Carcinoma Tumor Tissue |
Primary outcome
Success rate for tumor RNA isolation and amplification
Time frame: At time of surgery or during biopsy
To Determine the success rate for tumor RNA isolation and amplification create a minimum of 10 doses of AGS-003, as defined by a minimum concentration of ≥84 µg/µL in typically greater than 150 µL final volume RNA. (Tissue obtained at time of surgery or biopsy depending on stage)
Results and safety
The study was stopped early (reason given: The sponsor's clinical program for the agent used in this study was discontinued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
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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.
Michael Harrison, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RNA extraction and amplification from biopsy specimens in people with Metastatic Renal Cell Carcinoma and Genitourinary Cancer (Bladder, Prostate or Testicular), run by Duke University 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 14 inclusion and 5 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 20 Dec 2018. 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: The sponsor's clinical program for the agent used in this study was discontinued.). 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?
Success rate for tumor RNA isolation and amplification (time frame: At time of surgery or during biopsy). 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 20 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.