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

Exact Sciences Corporation35 sites in 1 country409 target enrollmentDecember 7, 2018

ConditionsHematologic Malignancy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hematologic Malignancy
Sponsor: Exact Sciences Corporation
Enrollment: 409
Locations: 35
Primary Endpoint: Blood-based biomarkers associated with genetic and epigenetic alterations.
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 7, 2018

End Date

March 24, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Exact Sciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.