Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer
Targeted Genomic Analysis of Human Cancers
5 other identifiers
observational
1,100
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
April 17, 2026
April 1, 2026
17.3 years
February 17, 2016
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Frequencies of individual specific mutations and combinations of mutations of related pathway genes
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.
Up to 15 years
Rate of actionable mutations in rare and/or poor prognosis cancers
The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate.
Up to 15 years
Study Arms (1)
Ancillary-Correlative (genomic 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.
Interventions
Undergo collection of blood samples
Eligibility Criteria
Persons with Cancer
You may qualify if:
- 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
You may not qualify if:
- Karnofsky/Lansky performance score \< 30
- Life expectancy \< 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- National Cancer Institute (NCI)collaborator
- Rutgers Cancer Institute of New Jerseycollaborator
Study Sites (11)
Ocean Medical Center
Brick, New Jersey, 08724, United States
Bayshore Community Hospital
Holmdel, New Jersey, 07733, United States
RWJBarnabas Health - Jersey City Medical Center, Jersey City
Jersey City, New Jersey, 07302, United States
Southern Ocean County Medical Center
Manahawkin, New Jersey, 08050, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Shridar Ganesan
Rutgers Cancer Institute of New Jersey
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Manager
Study Record Dates
First Submitted
February 17, 2016
First Posted
February 23, 2016
Study Start
February 1, 2013
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share