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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01812 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CINJ # 001209 | |||
| 001209 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| Pro2012002075 | Other Identifier | Rutgers |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Persons with Cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office | Contact | 732-235-2465 |
| Name | Affiliation | Role |
|---|---|---|
| Shridar Ganesan | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocean Medical Center | Completed | Brick | New Jersey | 08724 | United States | |
| Bayshore Community Hospital |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Completed |
| Holmdel |
| New Jersey |
| 07733 |
| United States |
| RWJBarnabas Health - Jersey City Medical Center, Jersey City | Recruiting | Jersey City | New Jersey | 07302 | United States |
|
| Southern Ocean County Medical Center | Completed | Manahawkin | New Jersey | 08050 | United States |
| Morristown Medical Center | Completed | Morristown | New Jersey | 07960 | United States |
| Jersey Shore Medical Center | Completed | Neptune City | New Jersey | 07753 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08903 | United States |
|
| Riverview Medical Center/Booker Cancer Center | Completed | Red Bank | New Jersey | 07701 | United States |
| Riverview Medical Center | Active, not recruiting | Red Bank | New Jersey | 07701 | United States |
| Overlook Hospital | Completed | Summit | New Jersey | 07902 | United States |
| University of Wisconsin Hospital and Clinics | Withdrawn | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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