Recruiting

Genomic Analysis

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT02688517

Conditions

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Cytology Specimen Collection Procedure

Laboratory Biomarker Analysis

Study Details

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.

Conditions

Malignant Neoplasm

Study ID

NCT02688517

Start date

Feb, 2013

Status verified date

Apr, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cytology Specimen Collection Procedure

Undergo collection of blood samples

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • Frequencies of individual specific mutations and combinations of mutations of related pathway genes [ Time Frame: Up to 15 years ]
  • Rate of actionable mutations in rare and/or poor prognosis cancers [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Office

732-235-2465

Locations

RWJBarnabas Health - Jersey City Medical Center, Jersey City

Recruiting

Jersey City, New Jersey, United States, 07302

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Clinical Trials Office

732-235-8675

Principal Investigator:

Gregory Riedlinger

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-04-17.