Clinical trial NCT03628651: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
Official title: 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Hepatocellular Carcinoma Surveillance
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 2150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age and older who have clinically diagnosed HCC or are negative for HCC following disease surveillance will be enrolled. Approximately 2100 subjects will be enrolled into the two groups, HCC subjects and control subjects.

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarker Identification
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Facey Medical Foundation
state: California
city: Newport Beach
country: United States
facility: Office of Dr. John D. Homan MD
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research
state: California
city: Poway
country: United States
facility: Alliance Clinical Research
state: California
city: Homestead
country: United States
facility: Medical Center of Homestead
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinc
state: Florida
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center, Inc.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Mercy Medical Research
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital (HFH)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Charlotte
country: United States
facility: CMC Center for Liver Disease
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Memphis
country: United States
facility: Methodist Healthcare University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Magnolia
country: United States
facility: ADP Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Newport News
country: United States
facility: Bon Secours Liver Institute of Hampton Roads
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Medical
state: Virginia
city: Spokane
country: United States
facility: South Perry Endoscopy
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Besançon
country: France
facility: CHU de Besancon Hopital Jean Minjoz
city: Caen
country: France
facility: CHU Caen
city: Créteil
country: France
facility: Hopital Henri Mondor
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Lille
country: France
facility: CHRU de LILLE - Hospital HURIEZ
city: Nancy
country: France
facility: Chru Brabois
city: Reims
country: France
facility: CHU Reims, Hopital Robert Debre
city: Rennes
country: France
facility: CHU Pontchaillou
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Koln
country: Germany
facility: Gastroenterologische Studienambulanz
city: Leipzig
country: Germany
facility: Universitat Leipzig
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitaet Magdeburg
city: München
country: Germany
facility: Medizinische Klinik und Poliklinik II
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola Malpighi
city: Cagliari
country: Italy
facility: AOU Cagliary
city: Messina
country: Italy
facility: A.O.U. Policlinico G.Martino
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Roma
country: Italy
facility: Ospedale Sant'Andrea Hospital
city: Alicante
country: Spain
facility: Hgu Alicante
city: Barcelona
country: Spain
facility: Hospital de Mar - Parc de Salut Mar
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Madrid
country: Spain
facility: Universidad Autonoma de Madrid - Hospital Universitario La Paz
city: Sabadell
country: Spain
facility: Parc Tauli Hospital Universitari
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Universitario de Rio Hortega
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Liver DIS Center
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center - Liuying
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Sririraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
Study officials:
affiliation: Exact Sciences
name: Laura Strong
role: STUDY_DIRECTOR
References:
citation: Chalasani NP, Porter K, Bhattacharya A, Book AJ, Neis BM, Xiong KM, Ramasubramanian TS, Edwards DK 5th, Chen I, Johnson S, Roberts LR, Kisiel JB, Reddy KR, Singal AG, Olson MC, Bruinsma JJ. Validation of a Novel Multitarget Blood Test Shows High Sensitivity to Detect Early Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2022 Jan;20(1):173-182.e7. doi: 10.1016/j.cgh.2021.08.010. Epub 2021 Aug 13.
citation: Chalasani NP, Ramasubramanian TS, Bhattacharya A, Olson MC, Edwards V DK, Roberts LR, Kisiel JB, Reddy KR, Lidgard GP, Johnson SC, Bruinsma JJ. A Novel Blood-Based Panel of Methylated DNA and Protein Markers for Detection of Early-Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2597-2605.e4. doi: 10.1016/j.cgh.2020.08.065. Epub 2020 Sep 2.