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

Sponsor

Exact Sciences Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT03727009

Collaborator

(none)

409

Enrollment

Locations

15.5

Actual Duration (Months)

11.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancy	Other: Blood Sample Collection

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.

Study Design

Study Type:

Observational

Actual Enrollment :

409 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 7, 2018

Actual Primary Completion Date :

Mar 24, 2020

Actual Study Completion Date :

Mar 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Blood Sample Collection Subjects participating in the study will have blood drawn at enrollment.

Arm

Intervention/Treatment

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.

Other: Blood Sample Collection

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Fort Smith	Fort Smith	Arkansas	United States	72903
2	CARTI Cancer Center	Little Rock	Arkansas	United States	72205
3	Marin Cancer Care	Greenbrae	California	United States	94904
4	Alliance Research Centers	Laguna Hills	California	United States	92653
5	North County Oncology	Oceanside	California	United States	92056
6	Middlesex Hospital	Middletown	Connecticut	United States	06457
7	The Stamford Hospital	Stamford	Connecticut	United States	06904
8	Mid-Florida Hematology and Oncology Center	Orange City	Florida	United States	32765
9	PMG Research, INC	Downers Grove	Illinois	United States	60515
10	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
11	Orchard Healthcare Research, Inc.	Skokie	Illinois	United States	60077
12	Carle Cancer Center NCI	Urbana	Illinois	United States	61801
13	Indiana Blood and Marrow Transportation	Indianapolis	Indiana	United States	46237
14	St. Elizabeth Medical Center	Edgewood	Kentucky	United States	41017
15	Baptist Health Lexington	Lexington	Kentucky	United States	40503
16	Baptist Health Louisville	Louisville	Kentucky	United States	40207
17	Baptist Health Paducah	Paducah	Kentucky	United States	42003
18	RCCA MD Inc.	Bethesda	Maryland	United States	20817
19	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan	United States	49503
20	HealthPartner Institute	Bloomington	Minnesota	United States	55425
21	Mercy Joplin	Joplin	Missouri	United States	64804
22	Mercy St. Louis	Saint Louis	Missouri	United States	63141
23	Mercy Springfield	Springfield	Missouri	United States	65804
24	East Carolina University Brody School of Medicine	Greenville	North Carolina	United States	27834
25	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina	United States	28374
26	Mercy Oklahoma City	Oklahoma City	Oklahoma	United States	73120
27	Bon Secours St Francis Cancer Center	Greenville	South Carolina	United States	29607
28	Spartanburg Regional Healthcare District	Spartanburg	South Carolina	United States	29301
29	Lexington Medical Center	West Columbia	South Carolina	United States	29169
30	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
31	Community Cancer Trials of Utah	Ogden	Utah	United States	84405
32	Wenatchee Valley Hospital	Wenatchee	Washington	United States	98801
33	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304
34	Dean Clinic - Fort Atkinson Specialty Services	Fort Atkinson	Wisconsin	United States	53538
35	ProHealth Care	Oconomowoc	Wisconsin	United States	53066

Sponsors and Collaborators

Exact Sciences Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Exact Sciences Corporation

ClinicalTrials.gov Identifier:

NCT03727009

Other Study ID Numbers:

2018-02

First Posted:

Nov 1, 2018

Last Update Posted:

Feb 3, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Exact Sciences Corporation

blood draw

sample collections

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Feb 3, 2021