Clinical trial NCT03727009: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies
Official title: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hematologic Malignancy
Keywords: blood draw
sample collections
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Blood-based biomarkers associated with genetic and epigenetic alterations.
timeFrame: Point in time blood collection (1 day) at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Mercy Fort Smith
state: Arkansas
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Oceanside
country: United States
facility: North County Oncology
state: California
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: Stamford
country: United States
facility: The Stamford Hospital
state: Connecticut
city: Orange City
country: United States
facility: Mid-Florida Hematology and Oncology Center
state: Florida
city: Downers Grove
country: United States
facility: PMG Research, INC
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research, Inc.
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center NCI
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transportation
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Paducah
country: United States
facility: Baptist Health Paducah
state: Kentucky
city: Bethesda
country: United States
facility: RCCA MD Inc.
state: Maryland
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Bloomington
country: United States
facility: HealthPartner Institute
state: Minnesota
city: Joplin
country: United States
facility: Mercy Joplin
state: Missouri
city: Saint Louis
country: United States
facility: Mercy St. Louis
state: Missouri
city: Springfield
country: United States
facility: Mercy Springfield
state: Missouri
city: Greenville
country: United States
facility: East Carolina University Brody School of Medicine
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Mercy Oklahoma City
state: Oklahoma
city: Greenville
country: United States
facility: Bon Secours St Francis Cancer Center
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare District
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: Fort Atkinson
country: United States
facility: Dean Clinic - Fort Atkinson Specialty Services
state: Wisconsin
city: Oconomowoc
country: United States
facility: ProHealth Care
state: Wisconsin
Study officials:
References: