Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

October 7, 2020 updated by: National Cancer Institute (NCI)

Clinical Sequencing of Cancer and Tissue Repository: ClinOmics

Background:

Saliva, blood, tissue, and cancer contain DNA. DNA makes the "instruction book" for the cells in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want to test DNA of people with tumors. They want to look for genetic changes in tumors that could be targets for treatment. Because DNA can change as cancer changes, more testing may be done at different times.

Objectives:

To find the DNA changes in cancer that may help guide treatment. To collect samples and data to be used in future studies.

Eligibility:

People any age with cancer or a pre-cancerous tumor

Design:

  • Participants will be screened with a medical history, physical exam, and blood tests. Participants will give a sample of their tumor. This is usually from a previous procedure. Participants will give a saliva or blood sample. They cannot eat, drink, smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon of saliva into a tube.
  • Some participants may have a punch biopsy instead. A small instrument will take a small piece of skin.
  • Researchers will collect data from participants medical records.
  • Participants will answer questions about their family health history. They will also answer questions about their views on the study, including possible unexpected results.
  • Extra blood or tissue samples may be taken at other times during the participants' treatment. All samples will be saved in secure ClinOmics freezers to be used in future studies.
  • Participants will be told by their doctors if any test results affect their health or their cancer treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Background:

  • Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for malignancies.
  • Omics investigation may identify novel drivers in the germline or tumor for high risk, relapsed, refractory or rare cancers.
  • Omics investigation may identify germline or somatic alterations that are medically actionable and or can enable precision therapy.

Objectives - Primary Objective:

-Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.

Eligibility - Adult or Pediatric patients of any age with one of the following:

  • Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer susceptibility familial syndromes, regardless of patient age; OR
  • Individuals without history of malignancy who are undergoing surgery; OR
  • Individuals without a history of cancer but evidence of an inherited cancer syndrome based on family history and/or other manifestations of a pre-cancerous syndrome (e.g. polyposis, plexiform neurofibromas, myelodysplastic disease); OR
  • Patient enrolled in an approved companion protocol.
  • Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues) that has been previously collected under CLIA and maintained in a CLIA lab which is available for CLIA analysis.
  • Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues) that has been previously collected and is available for research analysis.
  • Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.
  • Individual may be undergoing treatment for malignancy, premalignant condition or receiving other care associated with an inherited cancer syndrome.
  • Patients may be referred to the Principal Investigator from outside institutions.
  • Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent OR
  • IRB waiver of the requirement for informed consent for specific types of tissue.

Design:

  • This study will allow for the collection of specimens for CLIA reporting of germline and somatic mutations. The study will also collect specimens for a Tissue Repository, and for other investigations as outlined below.

  • CLIA testing activities will include

    • DNA extracted from a section of tumor, malignant tissue, blood, or bone marrow samples for somatic mutation sequence analysis
    • Germline DNA extracted from lymphocytes, saliva, skin, or any normal uninvolved tissues for sequence analysis to identify somatic alterations in the cancer and for the reporting of incidental findings of established clinical validity and utility.

  • Research activities may include:

    • DNA, RNA and protein Omics analyses from extracted normal and/or tumor tissues; the remainder of the tumor tissue will be stored.
    • Germline DNA and RNA analyses from extracted lymphocytes or other normal uninvolved tissue.
    • T (TCR) or B Cell Receptor sequencing from blood, tumor, or malignant tissue.
    • Establishing Patient-Derived Models such as patient-derived xenografts (PDXs), early-passage in vitro tumor cultures, and organoid cultures, conditionally reprogrammed cells (CRC) lines, explant and cell lines from tumor or normal samples by the NCI Patient-Derived Models Repository (PDMR) at Frederick National Laboratory for Cancer Research or by the OncoGenomics laboratory.
    • Cryopreservation of viable normal (e.g. PBMC) or malignant tissues.
    • Establishment of EBV transformed cell lines from blood for medical research either by Coriell Institute or by investigators on this protocol.
    • Omics (Genomics, Proteomic, Epigenetics, Metabolomics) studies will be performed.
  • Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples for the population cohort will be selected from patients that are co-enrolled on other NIH protocols (both inpatient and outpatient) as well as community referrals from outside NIH.

Description

  • INCLUSION CRITERIA:

Adult or Pediatric patients with one of the following:

  • Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer susceptibility familial syndromes, regardless of patient age; OR
  • Individuals without history of malignancy who are undergoing surgery; OR
  • Individuals without a history of cancer but evidence of an inherited cancer syndrome based on family history and/or other manifestations of the syndrome (i.e. polyposis, plexiform neurofibromas, myelodysplastic syndrome); OR
  • Tissue (including tumor, normal, blood, serum, plasma, or other tissues) that has been previously collected under CLIA and maintained in a CLIA lab which is available for CLIA analysis.
  • Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues) that has been previously collected and is available for research analysis.
  • Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.
  • Individual may be undergoing treatment for malignancy, premalignant condition or receiving other care associated with an inherited cancer syndrome.
  • Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent; OR
  • IRB waiver of the requirement for informed consent for specific types of tissue.

EXCLUSION CRITERIA:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group A
Adult/pediatric with suspected or confirmed malignancy, family history of malignancy, undergoing surgery with no malignancy; tissues collected previously under CLIA or for research.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.
Time Frame: ongoing
Sample analysis.
ongoing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues
Time Frame: ongoing
Sample analysis for identification of biomarkers, drivers and medically actionable targets for clinical management.
ongoing
Create a tissue repository
Time Frame: ongoing
Repository for analysis of samples.
ongoing
Extraction and storage of circulating tumor DNA
Time Frame: ongoing
Storage of samples.
ongoing
Establishing Patient-derived models
Time Frame: ongoing
Analysis of samples.
ongoing
Cryopreservation of viable tumor tissue for future study
Time Frame: ongoing
Sample storage for future analysis.
ongoing
Establishment of EBV transformed cell lines for research
Time Frame: ongoing
Analysis of germline samples.
ongoing
Creation of an OncoGenomics oversight committee
Time Frame: ongoing
Oversight and development of new treatment approaches.
ongoing
Assessment of effects of the informed consent process
Time Frame: ongoing
Survey data collection and analysis.
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 170040
  • 17-C-0040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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