Carcinoma, Hepatocellulare:Med-HCC-1NCT02372162
Fingerprint Characterization of Advanced HCC
An observational study of Carcinoma, Hepatocellular, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This single center, open-label, uncontrolled, non-randomized observational study in patients with advanced HCC. The patients qualify either to a local treatment with transarterial chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Image Fingerprint and Molecular Fingerprint
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to 1 Jun 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18, of both genders, with advanced stage hepatocellular carcinoma, for Group A BCLC class B (intermediate stage, performance status-ECOG 0, multinodular HCC), for Group B BCLC class B or C (advanced stage, performance status-ECOG 1-2, invasive tumor pattern (vascular invasion/extra hepatic spread)). Number: Up to 20 patients to receive therapy with TACE (Group A) and up to 20 patients to receive Sorafenib as first-line systemic therapy (Group B).
Who may be able to join
- All inclusion criteria must be met at the time of screening unless otherwise specified:
- Male or female ≥ 18 years.
- Written informed consent obtained prior to any trial specific procedure.
- Advanced stage hepatocellular carcinoma, BCLC class B for Group A and BCLC class B or C for Group B (refer to Appendix 3 for BCLC classification).
- Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included. Patients with untreatable ascites or hepatic encephalopathy > Grade 1 are excluded (see exclusion criteria; (refer to Appendix 4 for Child Pugh classification)).
- Indication for TACE or sorafenib treatment confirmed by an interdisciplinary tumor board.
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- ECOG performance status 0, 1 or 2 (refer to Appendix 2 for definitions of ECOG grades).
- Life expectancy of 12 weeks or more.
- Adequate hematological parameters, as demonstrated by:
- Hemoglobin ≥ 9.0 g/dl (SI units: 5.6 mmol/l);
- WBC ≥ 3.0 x 109/l;
- Absolute neutrophil count ≥1,500/mm3;
- Platelets ≥ 75 x 109/l;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal range (ULNR);
- Bilirubin ≤ 3 mg/dl;
- Serum creatinine ≤ 1.5 mg/dl (SI units: 132 µmol/l);
- Prothrombin Time (PT) International Normalized Ratio (INR) ≤ 1,5;
- Serum potassium, magnesium and calcium within normal range.
- Safe contraception in females of childbearing potential during the entire study using an established treatment with hormonal contraceptives for at least 2 months prior to start of screening.
- For females of child bearing potential (without using hormonal contraceptives for at least 2 months prior to start of screening) a double contraception method is requested during the entire study meeting the criteria for an effective method of birth control. That means at least two effective birth control methods such as condoms, diaphragms or intra-uterine devices must be used.
- Male patients with partners of child bearing potential are requested to use barrier contraception in addition to having their partner use another method of contraception during the trial and for 3 months after the last dose. Male patients will also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.
- Able to comply with all the requirements of the protocol.
Who cannot join
- Patients who meet any of the following criteria are not eligible for study participation:
- Renal failure requiring hemo- or peritoneal dialysis.
- Known central nervous system (CNS) tumors including symptomatic brain metastasis.
- Patients with no adequate treatment for gastrointestinal bleeding and esophagus varices within 14 days prior to study entry.
- Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I (see Child-Pugh index, Appendix 4).
- History and current cardiovascular complications, including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, a condition requiring anti arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
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- Current evidence of any severe internal, psychiatric or neurologic disease.
- Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.
- Pregnant or breastfeeding women.
- Active alcohol and/or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fingerprint Characterization of Advanced HCC to Optimize Treatment Decisions and Enable an Early Prediction of Therapy Resistance (HCC Multiscale Trial-1)
This single center, open-label, uncontrolled, non-randomized observational study in patients with advanced HCC. The patients qualify either to a local treatment with transarterial chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib. The aim of this feasibility study is to get a comprehensive image and molecular fingerprint of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve the care of patients that get progressive disease under treatment, the investigators have to improve the investigators understanding of the development of therapy resistance, which will improve patient care at the time point of progressive disease. Therefore, the data of 20 patients in each group will be used to identify molecular and / or image patterns, that can be used to predict treatment responses and thus govern an optimized individual cancer treatment for patients with advanced HCC.
Read the detailed description
A single-center, open-label, uncontrolled, non-randomized clinical trial. The two treatment groups to receive:
Group A Transarterial Chemoembolization (TACE): 20 patients that are treated with TACE will get an image and molecular fingerprint of the tumor prior to the first treatment with TACE, a second image fingerprint between week 2 - 4 after the first treatment with TACE, and a third image and molecular fingerprint at the time point of progressive disease.
Group B Sorafenib: 20 patients that are treated with Sorafenib will get an image and molecular fingerprint of the tumor prior to the first treatment, between week 2 and 3 after the start of treatment and at the time point of progressive disease.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Image Fingerprint, Molecular Fingerprint
- Keywords
- Hepatocellular Carcinoma, Molecular Diagnostics, Sorafenib, Therapeutic chemoembolization, Next-generation sequencing, Sequence analysis, DNA, Sequence analysis, RNA, Metabolomics
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image FingerprintOther
This is an observational study that uses in depth diagnostic procedures to characterize patients with a comprehensive Image Fingerprint that includes CT, MRI and PET diagnostics
Molecular FingerprintOther
This is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| Group A - TACE | Patients with transarterial chemoembolization (TACE) will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo. Receives: Other: Image Fingerprint; Other: Molecular Fingerprint | |
| Group B - Sorafenib | Patients with Sorafenib treatment will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo. Receives: Other: Image Fingerprint; Other: Molecular Fingerprint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Availability of comprehensive imaging and molecular fingerprint data of individual tumors
The aim of this feasibility study is to get comprehensive image and molecular fingerprints of individual tumors that can be used for systems biology approaches to predict therapy outcome and govern therapeutic decisions.
Measured: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Secondary outcomes (9)
Determination of turnaround time for image and molecular data availability
To set-up and optimize the workflow of data gathering and analysis for molecular and image fingerprints.
Measured: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Description of correlations between image and molecular data
Correlation of results from image and molecular fingerprints at one point of time
Measured: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Description of correlations between image and molecular data
Correlation of either image or molecular fingerprints at three different time points
Measured: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Identification of molecular and image patterns of treatment failure
To identify molecular and image patterns of early treatment failure.
Measured: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months
Identification of molecular and image patterns of treatment success
To identify molecular and image patterns of early treatment success
Measured: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months
Comparison of molecular and image pattern fingerprints in patients and animal models
To compare molecular and image patterns from HCC patients with respective patterns from different animal models which might identify suitable preclinical models for different clinical tumor patterns.
Measured: Evaluation within 48 months
Identification of early outcome prediction patterns
To determine ideal imaging methods for an early prediction of progressive disease
Measured: Evaluation within 48 months
To provide data for a molecular diagnostic board
To set up a molecular diagnostic board that checks for data-based tailored treatment options
Measured: Each individual patient will be evaluated as soon as data sets are available within this feasibility study
Biomarker analysis
To identify clinical relevant biomarkers from tumor tissue or blood / urine analysis
Measured: Evaluation within 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJul 2015
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Michael Bitzer, University Hospital Tuebingen
- Investigators
- Michael Bitzer, MD, Principal investigator, University Clinic, Eberhard Karls University, Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372162
- Sponsor's protocol ID
- e:Med Tuebingen, Protocol #1
- Acronym
- e:Med-HCC-1
- Status last verified
- Jun 2019
- First submitted
- 9 Oct 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fingerprint Characterization of Advanced HCC to Optimize Treatment Decisions and Enable an Early Prediction of Therapy Resistance (HCC Multiscale Trial-1)
- ClinicalTrials.gov ID
- NCT02372162
- Acronym / sponsor ID
- e:Med-HCC-1 / e:Med Tuebingen, Protocol #1
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular Carcinoma, Molecular Diagnostics, Sorafenib, Therapeutic chemoembolization, Next-generation sequencing, Sequence analysis, DNA, Sequence analysis, RNA, Metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2015
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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.
This single center, open-label, uncontrolled, non-randomized observational study in patients with advanced HCC. The patients qualify either to a local treatment with transarterial chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib. The aim of this feasibility study is to get a comprehensive image and molecular fingerprint of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve the care of patients that get progressive disease under treatment, the investigators have to improve the investigators understanding of the development of therapy resistance, which will improve patient care at the time point of progressive disease. Therefore, the data of 20 patients in each group will be used to identify molecular and / or image patterns, that can be used to predict treatment responses and thus govern an optimized individual cancer treatment for patients with advanced HCC.
Detailed description
A single-center, open-label, uncontrolled, non-randomized clinical trial. The two treatment groups to receive:
Group A Transarterial Chemoembolization (TACE): 20 patients that are treated with TACE will get an image and molecular fingerprint of the tumor prior to the first treatment with TACE, a second image fingerprint between week 2 - 4 after the first treatment with TACE, and a third image and molecular fingerprint at the time point of progressive disease.
Group B Sorafenib: 20 patients that are treated with Sorafenib will get an image and molecular fingerprint of the tumor prior to the first treatment, between week 2 and 3 after the start of treatment and at the time point of progressive disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - TACE | – | Other: Image Fingerprint, Other: Molecular FingerprintPatients with transarterial chemoembolization (TACE) will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo. |
| Group B - Sorafenib | – | Other: Image Fingerprint, Other: Molecular FingerprintPatients with Sorafenib treatment will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18, of both genders, with advanced stage hepatocellular carcinoma, for Group A BCLC class B (intermediate stage, performance status-ECOG 0, multinodular HCC), for Group B BCLC class B or C (advanced stage, performance status-ECOG 1-2, invasive tumor pattern (vascular invasion/extra hepatic spread)). Number: Up to 20 patients to receive therapy with TACE (Group A) and up to 20 patients to receive Sorafenib as first-line systemic therapy (Group B).
Key inclusion criteria (22 listed)
- Male or female ≥ 18 years.
- Written informed consent obtained prior to any trial specific procedure.
- Advanced stage hepatocellular carcinoma, BCLC class B for Group A and BCLC class B or C for Group B (refer to Appendix 3 for BCLC classification).
- Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included. Patients with untreatable ascites or hepatic encephalopathy > Grade 1 are excluded (see exclusion criteria; (refer to Appendix 4 for Child Pugh classification)).
- Indication for TACE or sorafenib treatment confirmed by an interdisciplinary tumor board.
Key exclusion criteria (10 listed)
- Renal failure requiring hemo- or peritoneal dialysis.
- Known central nervous system (CNS) tumors including symptomatic brain metastasis.
- Patients with no adequate treatment for gastrointestinal bleeding and esophagus varices within 14 days prior to study entry.
- Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I (see Child-Pugh index, Appendix 4).
- History and current cardiovascular complications, including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, a condition requiring anti arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
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 |
|---|---|---|
| Image FingerprintThis is an observational study that uses in depth diagnostic procedures to characterize patients with a comprehensive Image Fingerprint that includes CT, MRI and PET diagnostics | Other | Group A - TACE, Group B - Sorafenib |
| Molecular FingerprintThis is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing | Other | Group A - TACE, Group B - Sorafenib |
Primary outcome
Availability of comprehensive imaging and molecular fingerprint data of individual tumors
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
The aim of this feasibility study is to get comprehensive image and molecular fingerprints of individual tumors that can be used for systems biology approaches to predict therapy outcome and govern therapeutic decisions.
9 secondary outcomes
Determination of turnaround time for image and molecular data availability
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Description of correlations between image and molecular data
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Description of correlations between image and molecular data
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Identification of molecular and image patterns of treatment failure
Time frame: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months
Identification of molecular and image patterns of treatment success
Time frame: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months
Comparison of molecular and image pattern fingerprints in patients and animal models
Time frame: Evaluation within 48 months
Identification of early outcome prediction patterns
Time frame: Evaluation within 48 months
To provide data for a molecular diagnostic board
Time frame: Each individual patient will be evaluated as soon as data sets are available within this feasibility study
Biomarker analysis
Time frame: Evaluation within 48 months
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 19 Jun 2019.
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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.
Michael Bitzer, MD principal investigator
University Clinic, Eberhard Karls University, Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by University Hospital Tuebingen at 1 site in Germany.
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 22 inclusion and 10 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Availability of comprehensive imaging and molecular fingerprint data of individual tumors (time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2019.