Hepatocellular CarcinomaNCT03628651
Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma Surveillance, run by Exact Sciences Corporation at 74 sites in 7 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Carcinoma Surveillance
- What is being tested?
- Blood Sample Collection
- How many people
- 2,150 participants
- Where
- 74 sitesin 7 countries
- Study dates
- 2 Apr 2018to 11 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All Subjects:
- Subject is 18 years of age or older
- 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:
Show all 10Show fewer
- Non-cancer subject undergoing routine imaging surveillance for HCC
- Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC.
- Control Group 1 - negative by ultrasound
- Control Group 2 - negative by CT or MRI
Who cannot join
- Known 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.
- Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
- Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood 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.
- 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.
Trial locations and contacts
74 sites in 7 countries.
74 sites in 7 countries
United States36 sites
University of Michigan
Ann Arbor, Michigan, 48109
ARC Clinical Research at Wilson Parke
Austin, Texas, 78726
Mercy Medical Research
Baltimore, Maryland, 21202
CMC Center for Liver Disease
Charlotte, North Carolina, 28210
OnSite Clinical Solutions
Charlotte, North Carolina, 28226
University of Virginia
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
UH Cleveland Medical Center
Cleveland, Ohio, 44106
UT Southwestern Medical Center
Dallas, Texas, 75201
Henry Ford Hospital (HFH)
Detroit, Michigan, 48202-2608
Medical Center of Homestead
Homestead, Florida, 33030
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
The Jackson Clinic
Jackson, Tennessee, 38301
Mayo Clinc
Jacksonville, Florida, 32224
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, 33319
Cedars Sinai Medical Center
Los Angeles, California, 90048
Facey Medical Foundation
Los Angeles, California, 91345
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
ADP Clinical Research
Magnolia, Texas, 77355
Methodist Healthcare University Hospital
Memphis, Tennessee, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Office of Dr. John D. Homan MD
Newport Beach, California, 92663-3668
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602
UC Irvine Health
Orange, California, 92868
FOMAT Medical Research
Oxnard, California, 93030
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Alliance Clinical Research
Poway, California, 92064
Hunter Holmes McGuire Medical
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
South Perry Endoscopy
Spokane, Washington, 99202
Stony Brook Cancer Center
Stony Brook, New York, 11794
Guardian Angel Research Center, Inc.
Tampa, Florida, 33614
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
Taiwan9 sites
Changhua Christian Hospital
Chang-hua, 50006
Kaohsiung Medical University Hospital
Kaohsiung City, 807
Chang Gung Medical Foundation
Kaohsiung City, 83301
China Medical University Hospital
Taichung, 40447
Liver DIS Center
Taichung, 40705
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 70403
Chi Mei Medical Center - Liuying
Tainan, 736
Chang Gung Medical Foundation
Taoyuan, 33305
France8 sites
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030
CHU Caen
Caen, 14000
Hopital Henri Mondor
Créteil, 94010
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700
CHRU de LILLE - Hospital HURIEZ
Lille, 59037
Chru Brabois
Nancy, 54500
CHU Reims, Hopital Robert Debre
Reims, 51092
CHU Pontchaillou
Rennes, 35000
Spain7 sites
Hgu Alicante
Alicante, 03010
Hospital de Mar - Parc de Salut Mar
Barcelona, 08003
Hospital Reina Sofia
Córdoba, 14014
Universidad Autonoma de Madrid - Hospital Universitario La Paz
Madrid, 28046
Parc Tauli Hospital Universitari
Sabadell, 08208
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Universitario de Rio Hortega
Valladolid, 47012
Germany6 sites
Helios Klinikum Berlin-Buch
Berlin, 13125
Universitätsklinikum Bonn
Bonn, 53105
Gastroenterologische Studienambulanz
Cologne, 50937
Universitat Leipzig
Leipzig, 04103
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, 39120
Medizinische Klinik und Poliklinik II
München, 81377
Italy5 sites
Policlinico Sant' Orsola Malpighi
Bologna, 40138
AOU Cagliary
Cagliari, 09042
A.O.U. Policlinico G.Martino
Messina, 98125
Ospedale San Gerardo
Monza, 20052
Ospedale Sant'Andrea Hospital
Roma, 00189
Thailand3 sites
Phramongkutklao Hospital
Bangkok, 10400
Sririraj Hospital
Bangkok, 10700
Chiang Mai University
Chiang Mai, 50200
About this study
Official title: 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
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).
Read the 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.
- Being tested
- Blood Sample Collection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
HCC subjects will have one blood sample collected.
Blood Sample CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HCC Surveillance | Approximately 1400 HCC surveillance subjects (controls) will be enrolled. Receives: Other: Blood Sample Collection | |
| HCC | Approximately 700 subjects with untreated clinically diagnosed HCC will be enrolled. Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start2 Apr 2018
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Strong, Study director, Exact Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628651
- Sponsor's protocol ID
- 2017-01
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2018
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.
Publications
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.
PubMed 34391922Chalasani 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.
PubMed 32889146
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03628651
- Acronym / sponsor ID
- 2017-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,150 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC Surveillance | – | Other: Blood Sample CollectionApproximately 1400 HCC surveillance subjects (controls) will be enrolled. |
| HCC | – | Other: Blood Sample CollectionApproximately 700 subjects with untreated clinically diagnosed HCC will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- All 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.
- Non-cancer subject undergoing routine imaging surveillance for HCC
- Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC.
Key exclusion criteria (8 listed)
- Known 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.
- Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
- Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionHCC subjects will have one blood sample collected. | Other | HCC |
| Blood Sample CollectionSurveillance 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. | Other | HCC Surveillance |
Primary outcome
Biomarker Identification
Time frame: 1 year
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 34391922Chalasani 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.
- Derived from this study: PubMed 32889146Chalasani 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Strong study director
Exact Sciences
74 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma Surveillance, run by Exact Sciences Corporation at 74 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Taiwan, France, Spain, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker Identification (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628651, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.