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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688517
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : December 20, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Shridar Ganesan, MD, PhD, Rutgers Cancer Institute of New Jersey

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Not Applicable

Detailed 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 whole 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 3 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted Genomic Analysis of Human Cancers
Study Start Date : February 2013
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
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Arm Intervention/treatment
Ancillary-Correlative (genomic analysis)
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 DNA and circulating tumor cells.
 Other: Cytology Specimen Collection Procedure
Undergo collection of blood samples
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Frequencies of individual specific mutations and combinations of mutations of related pathway genes [ Time Frame: Up to 5 years ]
    Descriptive analysis will be used to determine frequencies of specific mutations and to determine the pathways that can be targeted most frequently in patients with rare/poor prognosis cancer.

  2. Rate of actionable mutations in rare and/or poor prognosis cancers [ Time Frame: Up to 5 years ]
    The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Karnofsky/Lansky performance score < 30
  • Life expectancy < 3 months
Contacts and Locations
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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): NCT02688517


Contacts
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Contact: Clinical Trials Office 732-235-2465

Locations
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United States, New Jersey
Ocean Medical Center Active, not recruiting
Brick, New Jersey, United States, 08724
Bayshore Community Hospital Active, not recruiting
Holmdel, New Jersey, United States, 07733
RWJBarnabas Health - Jersey City Medical Center, Jersey City Recruiting
Jersey City, New Jersey, United States, 07302
Contact: Shridar Ganesan         
Southern Ocean County Medical Center Active, not recruiting
Manahawkin, New Jersey, United States, 08050
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07960
Jersey Shore Medical Center Active, not recruiting
Neptune, New Jersey, United States, 07753
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office    732-235-8675      
Principal Investigator: Shridar Ganesan         
Riverview Medical Center/Booker Cancer Center Active, not recruiting
Red Bank, New Jersey, United States, 07701
Riverview Medical Center Active, not recruiting
Red Bank, New Jersey, United States, 07701
Overlook Hospital Active, not recruiting
Summit, New Jersey, United States, 07902
United States, Wisconsin
University of Wisconsin Hospital and Clinics Withdrawn
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Shridar Ganesan Rutgers Cancer Institute of New Jersey
More Information
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Responsible Party: Shridar Ganesan, MD, PhD, Associate Professor of Medicine and Pharmacology Medical Oncology, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT02688517    
Other Study ID Numbers: Pro2012002075
NCI-2015-01812 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CINJ # 001209
001209 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
Pro2012002075 ( Other Identifier: Rutgers )
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms