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

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ClinicalTrials.gov Identifier: NCT02026960
Recruitment Status : Terminated (The sponsor's clinical program for the agent used in this study was discontinued.)
First Posted : January 3, 2014
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Argos Therapeutics
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Genitourinary Cancer (Bladder, Prostate or Testicular) Device: RNA extraction and amplification from biopsy specimens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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



Primary Outcome Measures :
  1. Success rate for tumor RNA isolation and amplification [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026960


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Argos Therapeutics
Investigators
Principal Investigator: Michael Harrison, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02026960     History of Changes
Other Study ID Numbers: Pro00047147
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases