Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer
- Conditions
- Malignant Neoplasm
- Interventions
- Other: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker Analysis
- Registration Number
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- 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
- Karnofsky/Lansky performance score < 30
- Life expectancy < 3 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (genomic analysis) Cytology Specimen Collection Procedure 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. Ancillary-Correlative (genomic analysis) Laboratory Biomarker Analysis 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Bayshore Community Hospital
🇺🇸Holmdel, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Jersey Shore Medical Center
🇺🇸Neptune, New Jersey, United States
Ocean Medical Center
🇺🇸Brick, New Jersey, United States
RWJBarnabas Health - Jersey City Medical Center, Jersey City
🇺🇸Jersey City, New Jersey, United States
Southern Ocean County Medical Center
🇺🇸Manahawkin, New Jersey, United States
Riverview Medical Center/Booker Cancer Center
🇺🇸Red Bank, New Jersey, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States