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

Malignant Neoplasm Clinical Trial

Official title:

Targeted Genomic Analysis of Human Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02688517
• Other study ID #: Pro2012002075
• Secondary ID: NCI-2015-01812CI
• Status: Recruiting
• Start date: February 2013
• Est. completion date: May 2030

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Clinical Trials Office
• Phone: 732-235-2465
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: May 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Ocean Medical Center	Brick	New Jersey
United States	Bayshore Community Hospital	Holmdel	New Jersey
United States	RWJBarnabas Health - Jersey City Medical Center, Jersey City	Jersey City	New Jersey
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Southern Ocean County Medical Center	Manahawkin	New Jersey
United States	Morristown Medical Center	Morristown	New Jersey
United States	Jersey Shore Medical Center	Neptune	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Riverview Medical Center/Booker Cancer Center	Red Bank	New Jersey
United States	Overlook Hospital	Summit	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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