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

Targeted Genomic Analysis of Human Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

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 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.

• Study Type: Observational
• Enrollment (Estimated): 1100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Office; Phone Number: 732-235-2465

Study Locations

• United States
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Completed
      • Ocean Medical Center
    • Holmdel, New Jersey, United States, 07733
      • Completed
      • Bayshore Community Hospital
    • Jersey City, New Jersey, United States, 07302
      • Recruiting
      • RWJBarnabas Health - Jersey City Medical Center, Jersey City
      • Contact: Gregory Riedlinger
    • Manahawkin, New Jersey, United States, 08050
      • Completed
      • Southern Ocean County Medical Center
    • Morristown, New Jersey, United States, 07960
      • Completed
      • Morristown Medical Center
    • Neptune City, New Jersey, United States, 07753
      • Completed
      • Jersey Shore Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Clinical Trials Office; Phone Number: 732-235-8675
      • Principal Investigator: Gregory Riedlinger
    • Red Bank, New Jersey, United States, 07701
      • Active, not recruiting
      • Riverview Medical Center
    • Red Bank, New Jersey, United States, 07701
      • Completed
      • Riverview Medical Center/Booker Cancer Center
    • Summit, New Jersey, United States, 07902
      • Completed
      • Overlook Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Withdrawn
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons with Cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: Laboratory Biomarker Analysis; Correlative studies; Other: Cytology Specimen Collection Procedure; Undergo collection of blood samples; Other Names: Cytologic Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequencies of individual specific mutations and combinations of mutations of related pathway genes	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.	Up to 15 years
Rate of actionable mutations in rare and/or poor prognosis cancers	The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate.	Up to 15 years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Investigators: Principal Investigator: Shridar Ganesan, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimated): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Pro2012002075 (Other Identifier: Rutgers); P30CA072720 (U.S. NIH Grant/Contract); NCI-2015-01812 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CINJ # 001209; 001209 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO