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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2030-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Detection of Tumor DNA in Blood Samples From Cancer Patients

NCT02288754

Cancer Tumors

UNKNOWN

Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

NCT03707574

Advanced Malignant Neoplasm Advanced Melanoma Advanced Renal Cell Carcinoma +51 more

ACTIVE_NOT_RECRUITING

Collection of Tissue & Blood From Patients w/ Benign & Malignant Tumors of the Soft Tissue & Gastrointestinal Tract

NCT00582647

Esophageal Cancer Bile Duct Neoplasms Gastric Cancer +4 more

ACTIVE_NOT_RECRUITING

Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma

NCT01585376

Sarcoma

COMPLETED

Discovering New Genetic Markers in Adults and Children Who May Be At Risk for Hereditary Forms of Cancer

NCT03922893

Cancer

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Cytology Specimen Collection Procedure

Intervention Type OTHER

Undergo collection of blood samples

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cytology Specimen Collection Procedure

Undergo collection of blood samples

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cytologic Sampling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shridar Ganesan, MD, PhD

Associate Professor of Medicine and Pharmacology Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shridar Ganesan

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.