NCT02026960

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

January 2, 2014

Last Update Submit

December 19, 2018

Conditions

Metastatic Renal Cell CarcinomaGenitourinary Cancer (Bladder, Prostate or Testicular)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

RNA extraction and amplification from biopsy specimensDEVICE
Genitourinary tumor tissue (Expansion cohort)Renal Cell Carcinoma Tumor Tissue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Tumor tissue is committed to other use or inadequate for RNA analysis.
  • Insufficient tissue is collected in the BRPC.
  • Expansion Cohort for Genitourinary Cancers:
  • 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.
  • Tumor tissue is committed to other use or inadequate for RNA analysis.
  • Insufficient tissue is collected in the BRPC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellUrogenital Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Michael Harrison, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 3, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

September 7, 2017

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

US(1)