Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies

February 2, 2021 updated by: Exact Sciences Corporation
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will have been recently diagnosed with an untreated hematologic malignancy. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
409

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
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Fort Smith
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care
      • Laguna Hills, California, United States, 92653
        • Alliance Research Centers
      • Oceanside, California, United States, 92056
        • North County Oncology
    • Connecticut
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital
      • Stamford, Connecticut, United States, 06904
        • The Stamford Hospital
    • Florida
      • Orange City, Florida, United States, 32765
        • Mid-Florida Hematology and Oncology Center
    • Illinois
      • Downers Grove, Illinois, United States, 60515
        • PMG Research, Inc
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research, Inc.
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center NCI
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood and Marrow Transportation
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Medical Center
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
      • Paducah, Kentucky, United States, 42003
        • Baptist Health Paducah
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • RCCA MD Inc.
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • HealthPartner Institute
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Mercy Joplin
      • Saint Louis, Missouri, United States, 63141
        • Mercy St. Louis
      • Springfield, Missouri, United States, 65804
        • Mercy Springfield
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University Brody School of Medicine
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Outpatient Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Oklahoma City
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours St Francis Cancer Center
      • Spartanburg, South Carolina, United States, 29301
        • Spartanburg Regional Healthcare District
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
    • Utah
      • Ogden, Utah, United States, 84405
        • Community Cancer Trials of Utah
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center
    • Wisconsin
      • Fort Atkinson, Wisconsin, United States, 53538
        • Dean Clinic - Fort Atkinson Specialty Services
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Care

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 500 subjects will be enrolled. Subjects will be men and women, 18 years of age and older, who have an untreated hematologic malignancy.

Description

Inclusion Criteria:

  • Subject is male or female ≥ 18 years of age.
  • Subject has an untreated hematologic malignancy.
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
  • Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
  • Any treatment for the primary malignancy. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment prior to blood sample collection.
  • Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
  • Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

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: Cohort
  • Time Perspectives: Cross-Sectional

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Hematologic Malignancy
Subjects with clinically confirmed hematologic malignancy and who are treatment naive will provide a blood sample at the time of enrollment. No additional blood draws will occur.
Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

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
Blood-based biomarkers associated with genetic and epigenetic alterations.
Time Frame: Point in time blood collection (1 day) at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with a hematologic malignancy at the pre-intervention stage.
Point in time blood collection (1 day) at enrollment

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.
Exact Sciences Corporation

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.
December 7, 2018

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.
March 24, 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.
March 24, 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).
October 23, 2018

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.
October 30, 2018

First Posted (Actual)

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.
November 1, 2018

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.
February 3, 2021

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.
February 2, 2021

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.
February 1, 2021

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.
  • 2018-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.

IPD Sharing Time Frame

Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

IPD Sharing Access Criteria

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

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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