RNA Extraction and Amplification From Biopsy Specimens in... | NCT02026960

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The sponsor's clinical program for the agent used in this study was discontinued.

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Sep 7, 2017Actual

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Jan 2, 2014

First Posted Date

Jan 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2018

Last Update Posted Date

Dec 20, 2018Actual

Name	Class
Argos Therapeutics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal Cell Carcinoma Tumor Tissue	Experimental		Device: RNA extraction and amplification from biopsy specimens
Genitourinary tumor tissue (Expansion cohort)	Experimental	Bladder, prostate or testicular cancer	Device: RNA extraction and amplification from biopsy specimens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RNA extraction and amplification from biopsy specimens	Device		Genitourinary tumor tissue (Expansion cohort) Renal Cell Carcinoma Tumor Tissue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate for tumor RNA isolation and amplification	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)	At time of surgery or during biopsy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002292	Carcinoma, Renal Cell
D014565	Urogenital Neoplasms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases