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

Terminated
Conditions
Hematologic Malignancy
Registration Number
NCT03727009
Lead Sponsor
Exact Sciences Corporation
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
409
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Blood-based biomarkers associated with genetic and epigenetic alterations.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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (35)

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

Scroll for more (25 remaining)
Mercy Fort Smith
🇺🇸Fort Smith, Arkansas, United States

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