Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

Last updated: August 3, 2023
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

Laboratory Biomarker Analysis

Cytology Specimen Collection Procedure

Clinical Study ID

NCT02688517
Pro2012002075
001209
P30CA072720
CINJ # 001209
Pro2012002075
NCI-2015-01812
  • Ages > 1
  • All Genders

Study Summary

This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Karnofsky/Lansky performance score >= 30
  • A signed written informed consent
  • Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history ofbiopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis withstandard therapy; priority will be given to rare cancers with poor prognosis and lackof effective standard therapy; study principal investigator (PI) or designee willreview and approve each case before enrollment
  • Paraffin blocks of the patient's tumor tissue are available and accessible foranalysis

Exclusion

Exclusion Criteria:

  • Karnofsky/Lansky performance score < 30
  • Life expectancy < 3 months

Study Design

Total Participants: 1100
Treatment Group(s): 2
Primary Treatment: Laboratory Biomarker Analysis
Phase:
Study Start date:
February 01, 2013
Estimated Completion Date:
May 31, 2030

Study Description

PRIMARY OBJECTIVES:

I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.

II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed.

III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data.

IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.

OUTLINE:

Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells.

After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.

Connect with a study center

  • Ocean Medical Center

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Ocean Medical Center

    Bricktown, New Jersey 08724
    United States

    Site Not Available

  • Bayshore Community Hospital

    Holmdel, New Jersey 07733
    United States

    Site Not Available

  • RWJBarnabas Health - Jersey City Medical Center, Jersey City

    Jersey City, New Jersey 07302
    United States

    Active - Recruiting

  • Southern Ocean County Medical Center

    Manahawkin, New Jersey 08050
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Jersey Shore Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Jersey Shore Medical Center

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • Riverview Medical Center

    Red Bank, New Jersey 07701
    United States

    Site Not Available

  • Riverview Medical Center/Booker Cancer Center

    Red Bank, New Jersey 07701
    United States

    Site Not Available

  • Overlook Hospital

    Summit, New Jersey 07902
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

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