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

Not Applicable

Terminated

• Conditions: Metastatic Renal Cell Carcinoma; Genitourinary Cancer (Bladder, Prostate or Testicular)
• Interventions: Device: RNA extraction and amplification from biopsy specimens

• Registration Number: NCT02026960
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-03
• Study Start: 2014-03
• Primary Completion: 2016-03
• Study Completion: 2017-09-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Cell Carcinoma Tumor Tissue	RNA extraction and amplification from biopsy specimens	-
Genitourinary tumor tissue (Expansion cohort)	RNA extraction and amplification from biopsy specimens	Bladder, prostate or testicular cancer

Primary Outcome Measures

Name	Time	Method
Success rate for tumor RNA isolation and amplification	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)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States