Malignant Neoplasm
Conditions
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.
Interventions
OTHERCytology Specimen Collection Procedure
Undergo collection of blood samples
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of individual specific mutations and combinations of mutations of related pathway genes | Up to 15 years | 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. |
| Rate of actionable mutations in rare and/or poor prognosis cancers | Up to 15 years | The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate. |
Countries
United States
Contacts
CONTACTClinical Trials Office
PRINCIPAL_INVESTIGATORShridar Ganesan
Rutgers Cancer Institute of New Jersey
Outcome results
None listed