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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02026960
• Other study ID #: Pro00047147
• Status: Terminated
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 7, 2017

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 7, 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• RNA extraction and amplification from biopsy specimens

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Argos Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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