RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
Stopped early · Not applicable
Conditions studied: Metastatic Renal Cell Carcinoma, Genitourinary Cancer (Bladder, Prostate or Testicular)
In brief
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.
Key facts
- Study ID
- NCT02026960
- Run by
- Duke University
- People needed
- 14
- Starts
- 2014-03-01
- Expected to finish
- 2017-09-07
- Last updated by the study team
- 2018-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
- ≥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.
You may not qualify if…
- Tumor tissue is committed to other use or inadequate for RNA analysis.
- Insufficient tissue is collected in the BRPC.
- Expansion Cohort for Genitourinary Cancers:
- Inclusion Criteria:
- 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.
- Exclusion Criteria:
- Tumor tissue is committed to other use or inadequate for RNA analysis.
- Insufficient tissue is collected in the BRPC.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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