Clinical trial NCT02688517: Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer
Official title: Targeted Genomic Analysis of Human Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2016-02-23
Enrollment: 1100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

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.

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

Primary outcomes:
measure: Frequencies of individual specific mutations and combinations of mutations of related pathway genes
timeFrame: Up to 15 years
measure: Rate of actionable mutations in rare and/or poor prognosis cancers
timeFrame: Up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brick
country: United States
facility: Ocean Medical Center
state: New Jersey
city: Holmdel
country: United States
facility: Bayshore Community Hospital
state: New Jersey
city: Jersey City
country: United States
facility: RWJBarnabas Health - Jersey City Medical Center, Jersey City
state: New Jersey
city: Manahawkin
country: United States
facility: Southern Ocean County Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center/Booker Cancer Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Shridar Ganesan
role: PRINCIPAL_INVESTIGATOR
References: