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

Duke University

Status: Terminated

Conditions: Metastatic Renal Cell Carcinoma; Genitourinary Cancer (Bladder, Prostate or Testicular)

Treatments: Device: RNA extraction and amplification from biopsy specimens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02026960

Pro00047147

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Renal Cell Carcinoma Tumor Tissue

Experimental group

Treatment:

Device: RNA extraction and amplification from biopsy specimens

Genitourinary tumor tissue (Expansion cohort)

Experimental group

Description:

Bladder, prostate or testicular cancer

Treatment:

Device: RNA extraction and amplification from biopsy specimens