Official Title
Targeted Genomic Analysis of Human Cancers
Brief Title
Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer
Protocol ID
NCT02688517
Lead Sponsor
Rutgers, The State University of New Jersey
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.
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.
Enrollment Count
1,100 participants
Eligibility 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
Filters
Malignant Neoplasm
RECRUITING
CHILD
ADULT
OLDER_ADULT