Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628651
• Other study ID #: 2017-01
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: March 11, 2020

Study information

• Verified date: August 2020
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

Description:

Subjects with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing HCC surveillance will be enrolled and have blood samples collected. Subjects undergoing HCC surveillance will be followed for up to 6 months. Another blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2150
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All Subjects:

1. Subject is 18 years of age or older

2. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of data, including personal health data, to the study investigator and sponsor

HCC Subjects:

1. Subject has a recent (within 6 months of enrollment) untreated clinically diagnosed hepatocellular carcinoma as defined by =1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.

Control Subjects:

1. Non-cancer subject undergoing routine imaging surveillance for HCC

2. Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC.

1. Control Group 1 - negative by ultrasound

2. Control Group 2 - negative by CT or MRI

Exclusion Criteria:

1. Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.

3. Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.

4. Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).

5. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

6. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.

7. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.

8. 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Surveillance

Intervention

Other:
• Blood Sample Collection
HCC subjects will have one blood sample collected.
• Blood Sample Collection
Surveillance subjects will have a blood sample collected and will be followed for up to 6 months. A second blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Locations

Country	Name	City	State
France	CHU de Besancon Hopital Jean Minjoz	Besançon
France	CHU Caen	Caen
France	Hopital Henri Mondor	Créteil
France	Centre Hospitalier Universitaire de Grenoble	La Tronche
France	CHRU de LILLE - Hospital HURIEZ	Lille
France	Chru Brabois	Nancy
France	CHU Reims, Hopital Robert Debre	Reims
France	CHU Pontchaillou	Rennes
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Gastroenterologische Studienambulanz	Koln
Germany	Universitat Leipzig	Leipzig
Germany	Otto-von-Guericke-Universitaet Magdeburg	Magdeburg
Germany	Medizinische Klinik und Poliklinik II	München
Italy	Policlinico Sant' Orsola Malpighi	Bologna
Italy	AOU Cagliary	Cagliari
Italy	A.O.U. Policlinico G.Martino	Messina
Italy	Ospedale San Gerardo	Monza
Italy	Ospedale Sant'Andrea Hospital	Roma
Spain	Hgu Alicante	Alicante
Spain	Hospital de Mar - Parc de Salut Mar	Barcelona
Spain	Hospital Reina Sofia	Córdoba
Spain	Universidad Autonoma de Madrid - Hospital Universitario La Paz	Madrid
Spain	Parc Tauli Hospital Universitari	Sabadell
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Universitario de Rio Hortega	Valladolid
Taiwan	Changhua Christian Hospital	Chang Hua
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Liver DIS Center	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Medical Center - Liuying	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chang Gung Medical Foundation	Taoyuan
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Sririraj Hospital	Bangkok
Thailand	Chiang Mai University	Chiang Mai
United States	University of Michigan	Ann Arbor	Michigan
United States	ARC Clinical Research at Wilson Parke	Austin	Texas
United States	Mercy Medical Research	Baltimore	Maryland
United States	CMC Center for Liver Disease	Charlotte	North Carolina
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	UH Cleveland Medical Center	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Hospital (HFH)	Detroit	Michigan
United States	Medical Center of Homestead	Homestead	Florida
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	The Jackson Clinic	Jackson	Tennessee
United States	Mayo Clinc	Jacksonville	Florida
United States	Precision Clinical Research, LLC	Lauderdale Lakes	Florida
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Facey Medical Foundation	Los Angeles	California
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	ADP Clinical Research	Magnolia	Texas
United States	Methodist Healthcare University Hospital	Memphis	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Office of Dr. John D. Homan MD	Newport Beach	California
United States	Bon Secours Liver Institute of Hampton Roads	Newport News	Virginia
United States	UC Irvine Health	Orange	California
United States	FOMAT Medical Research	Oxnard	California
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Alliance Clinical Research	Poway	California
United States	Hunter Holmes McGuire Medical	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	South Perry Endoscopy	Spokane	Washington
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	Guardian Angel Research Center, Inc.	Tampa	Florida
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker Identification	Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with HCC compared to those without (but are at risk of developing the disease so are under surveillance)	1 year