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

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Malignant Neoplasm

Treatments: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02688517

Pro2012002075 (Other Identifier)

001209 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

CINJ # 001209

NCI-2015-01812 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

1,100 participants in 1 patient group

Ancillary-Correlative (genomic analysis)

Description:

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.

Treatment:

Other: Cytology Specimen Collection Procedure

Other: Laboratory Biomarker Analysis