Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

Official title

Targeted Genomic Analysis of Human Cancers

Overview

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

• Other Cytology Specimen Collection Procedure
  Undergo collection of blood samples
• Other Laboratory Biomarker Analysis
  Correlative studies

Primary outcome measures

• Frequencies of individual specific mutations and combinations of mutations of related pathway genes [Time frame: Up to 15 years]
• Rate of actionable mutations in rare and/or poor prognosis cancers [Time frame: Up to 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 11 centers

• Ocean Medical Center — Brick
• Bayshore Community Hospital — Holmdel
• RWJBarnabas Health - Jersey City Medical Center, Jersey City — Jersey City
• Southern Ocean County Medical Center — Manahawkin
• Morristown Medical Center — Morristown
• Jersey Shore Medical Center — Neptune City
• Rutgers Cancer Institute of New Jersey — New Brunswick
• Riverview Medical Center/Booker Cancer Center — Red Bank
• … and 3 more centers

Publications

• Blaszczyk MB, Boukhar SA, Zhou Z, Berim L, Ganesan S, Riedlinger GM. Occult collision tumor of the gastroesophageal junction comprising adenocarcinomas with distinct molecular profiles. Cancer Genet. 2025 Apr;292-293:27-34. doi: 10.1016/j.cancergen.2025.01.001. Epub 2025 Jan 4. PMID 39805155

Identifiers

NCT: NCT02688517 · Pro2012002075 · NCI-2015-01812 · CINJ # 001209 · 001209 · P30CA072720 · Pro2012002075

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗