RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:March 2014
End Date:September 7, 2017

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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.


Inclusion Criteria:

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:

1. 18 years of age or older.

2. Suspected RCC, in the opinion of the investigator

3. Availability of either:

- Nephrectomy or other surgically removed tissue (Stage I); or,

- Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage
II).

4. ≥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.

5. Not currently being treated with systemic therapy.

Exclusion Criteria:

1. Tumor tissue is committed to other use or inadequate for RNA analysis.

2. Insufficient tissue is collected in the BRPC.

Expansion Cohort for Genitourinary Cancers:

Inclusion Criteria:

1. 18 years of age or older

2. Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.

3. Availability of surgically removed tissue or biopsy tissue.

4. At least 2 biopsy specimens available from BRPC

5. Not currently being treated with systemic therapy.

Exclusion Criteria:

1. Tumor tissue is committed to other use or inadequate for RNA analysis.

2. Insufficient tissue is collected in the BRPC.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Michael Harrison, MD
Phone: 919-681-9822
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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