Bladder Cancer Clinical Trial

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

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. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.

View Eligibility Criteria

Eligibility Criteria

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:

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.

Exclusion Criteria:

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.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

14

Study ID:

NCT02026960

Recruitment Status:

Terminated

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

14

Study ID:

NCT02026960

Recruitment Status:

Terminated

Sponsor:


Duke University

How clear is this clinincal trial information?

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