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An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

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Trial Information

An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer


1. To measure the time from biopsy to completion and final analysis of Whole Genome
Sequencing (WGS) on patient tumor and non-tumor samples.

2. To examine the frequency with which useable sequence data is obtained as a function of
tumor volume received and percent tumor involvement in the biopsy

3. To identify the frequency with which potential targets and pathways for therapy are
discovered.

4. To observe for any evidence that if anti-tumor activity from treatment is noted how
would the genome sequencing have correlated with that activity.


Inclusion Criteria:



- Have a life expectancy of greater than 3 months.

- Patients must have a diagnosis of histologically or cytologically confirmed advanced
incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal
or biological regimens for advanced disease.

- Be a good medical candidate for and willing to undergo a biopsy or surgical procedure
to obtain tissue, which may or may not be part of the patient's routine care for
their malignancy.

Exclusion Criteria:

- Patients with symptomatic CNS metastasis.

- Known HIV, HBV or HCV infection requiring antiviral therapy.

- Pregnant or breast-feeding patients or any patient with childbearing potential not
using adequate contraception.

- Inaccessible tumor for biopsy

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Glen J Weiss, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scottsdale Healthcare

Authority:

United States: Institutional Review Board

Study ID:

SCRI-CA_004

NCT ID:

NCT01443390

Start Date:

September 2011

Completion Date:

March 2014

Related Keywords:

  • Advanced Cancer
  • Whole genome sequencing
  • Advanced Refractory Cancer
  • Neoplasms

Name

Location

Virginia G. Piper Cancer Center Clinical Trials at Scottsdale HealthcareScottsdale, Arizona  85258