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

Stopped early

Conditions studied: Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT03727009

Run by

Exact Sciences Corporation

People needed

409

Starts

2018-12-07

Expected to finish

2020-03-24

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mercy Fort Smith — Fort Smith, Arkansas, United States
• CARTI Cancer Center — Little Rock, Arkansas, United States
• Marin Cancer Care — Greenbrae, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• North County Oncology — Oceanside, California, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• The Stamford Hospital — Stamford, Connecticut, United States
• Mid-Florida Hematology and Oncology Center — Orange City, Florida, United States
• PMG Research, INC — Downers Grove, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Orchard Healthcare Research, Inc. — Skokie, Illinois, United States
• Carle Cancer Center NCI — Urbana, Illinois, United States
• Indiana Blood and Marrow Transportation — Indianapolis, Indiana, United States
• St. Elizabeth Medical Center — Edgewood, Kentucky, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Baptist Health Louisville — Louisville, Kentucky, United States
• Baptist Health Paducah — Paducah, Kentucky, United States
• RCCA MD Inc. — Bethesda, Maryland, United States
• Cancer Research Consortium of West Michigan — Grand Rapids, Michigan, United States
• HealthPartner Institute — Bloomington, Minnesota, United States
• Mercy Joplin — Joplin, Missouri, United States
• Mercy Springfield — Springfield, Missouri, United States
• Mercy St. Louis — St Louis, Missouri, United States
• East Carolina University Brody School of Medicine — Greenville, North Carolina, United States
• FirstHealth Outpatient Cancer Center — Pinehurst, North Carolina, United States

Full record on ClinicalTrials.gov

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