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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorRutgers, The State University of New Jersey

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Karnofsky/Lansky performance score < 30

Life expectancy < 3 months

Trial population

Persons with Cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cytology Specimen Collection Procedure

    Other intervention

    Undergo collection of blood samples

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

1,100 Participants
are divided into 1 treatment group
Group A: Ancillary-Correlative (genomic analysis)2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 15 years
2

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.

Time frame
Up to 15 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Rutgers Cancer Institute of New Jersey

Collaborator