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

NCT ID: NCT02026960

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-09-07

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Renal Cell Carcinoma Tumor Tissue

Group Type EXPERIMENTAL

RNA extraction and amplification from biopsy specimens

Intervention Type DEVICE

Genitourinary tumor tissue (Expansion cohort)

Bladder, prostate or testicular cancer

Group Type EXPERIMENTAL

RNA extraction and amplification from biopsy specimens

Intervention Type DEVICE

Interventions

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RNA extraction and amplification from biopsy specimens

Intervention Type DEVICE

Eligibility Criteria

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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.


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.

Expansion Cohort for Genitourinary Cancers:


1. Tumor tissue is committed to other use or inadequate for RNA analysis.
2. Insufficient tissue is collected in the BRPC.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Argos Therapeutics

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Harrison, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00047147

Identifier Type: -

Identifier Source: org_study_id