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

NCT ID: NCT03727009

Last Updated: 2021-02-03

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

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Recruitment Status

TERMINATED

Total Enrollment

409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-07

Study Completion Date

2020-03-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematologic Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Blood Sample Collection

Intervention Type OTHER

Subjects participating in the study will have blood drawn at enrollment.

Interventions

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Blood Sample Collection

Subjects participating in the study will have blood drawn at enrollment.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exact Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mercy Fort Smith

Fort Smith, Arkansas, United States

Site Status

CARTI Cancer Center

Little Rock, Arkansas, United States

Site Status

Marin Cancer Care

Greenbrae, California, United States

Site Status

Alliance Research Centers

Laguna Hills, California, United States

Site Status

North County Oncology

Oceanside, California, United States

Site Status

Middlesex Hospital

Middletown, Connecticut, United States

Site Status

The Stamford Hospital

Stamford, Connecticut, United States

Site Status

Mid-Florida Hematology and Oncology Center

Orange City, Florida, United States

Site Status

PMG Research, INC

Downers Grove, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Orchard Healthcare Research, Inc.

Skokie, Illinois, United States

Site Status

Carle Cancer Center NCI

Urbana, Illinois, United States

Site Status

Indiana Blood and Marrow Transportation

Indianapolis, Indiana, United States

Site Status

St. Elizabeth Medical Center

Edgewood, Kentucky, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

Baptist Health Louisville

Louisville, Kentucky, United States

Site Status

Baptist Health Paducah

Paducah, Kentucky, United States

Site Status

RCCA MD Inc.

Bethesda, Maryland, United States

Site Status

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, United States

Site Status

HealthPartner Institute

Bloomington, Minnesota, United States

Site Status

Mercy Joplin

Joplin, Missouri, United States

Site Status

Mercy Springfield

Springfield, Missouri, United States

Site Status

Mercy St. Louis

St Louis, Missouri, United States

Site Status

East Carolina University Brody School of Medicine

Greenville, North Carolina, United States

Site Status

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

Site Status

Mercy Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Bon Secours St Francis Cancer Center

Greenville, South Carolina, United States

Site Status

Spartanburg Regional Healthcare District

Spartanburg, South Carolina, United States

Site Status

Lexington Medical Center

West Columbia, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Community Cancer Trials of Utah

Ogden, Utah, United States

Site Status

Wenatchee Valley Hospital

Wenatchee, Washington, United States

Site Status

CAMC Clinical Trials Center

Charleston, West Virginia, United States

Site Status

Dean Clinic - Fort Atkinson Specialty Services

Fort Atkinson, Wisconsin, United States

Site Status

ProHealth Care

Oconomowoc, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2018-02

Identifier Type: -

Identifier Source: org_study_id

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