Hepatocellular CarcinomaNCT03162198
Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
An observational study of Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for inclusion.Based on the previous years data of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cirrhosis with HCC and Cirrhosis without HCC
- How many people
- 53 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2017to 31 Oct 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Proven cirrhosis with HCC proven by standard radiological criteria within last 1 month. * Proven cirrhosis with no HCC on dynamic CT and/or dynamic MRI done within last 1 month.
Who may be able to join
- Age between 18-70 years.
- Proven cirrhosis (Defined in appendix 1).
- HCC proven by standard radiological criteria within last 1-month (For Cases)
- No HCC on dynamic CT and/or dynamic MRI (protocol defined in appendix 1) done within last 1 month (For Control Group).
Who cannot join
- Previous biopsy or FNA of the tumor.
- Previous invasive radiological procedures TACE/RFA.
- Previous or ongoing chemotherapy or biological therapy.
- Previous liver resection or transplant.
- Segmental / main PV thrombosis.
- Atypical enhancement on imaging
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- Extrahepatic metastatic spread of HCC
- >70 years of age
- Coexisting sepsis.
- Renal dysfunction, as defined by serum creatinine >1.5mg/dL.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for inclusion.Based on the previous years data of HCC patients admitted to ILBS.
Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the Study of Liver Disease (AASLD) guidelines (details in appendix1).
Read more
Age and gender matched patients with cirrhosis, but without HCC, seen during the same study period will serve as controls.
Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted. Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cirrhosis with HCC, Cirrhosis without HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cirrhosis with HCCOther
Cirrhosis with Hepatocellular Carcinoma
Cirrhosis without HCCOther
Cirrhosis without Hepatocellular Carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis with HCC | Not described Receives: Other: Cirrhosis with HCC | |
| Cirrhosis without HCC | Not described Receives: Other: Cirrhosis without HCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)
Measured: Day 0
Number of cell-free DNA (cfDNA) in cirrhotic patients with hepatocellular carcinoma (HCC)
Measured: Day 0
Secondary outcomes (8)
Number of Circulating Tumor Cells in the peripheral blood of cirrhotic patients in both groups
Measured: Day 0
To study the difference in amount of cfDNA in the peripheral blood of cirrhotic patients with and without HCC.
Difference would be found out by estimating cfDNA in terms of ng/mL of the blood specimen
Measured: Day 0
Number of Circulatory Tumor Cells with the tumor size of HepatoCellular Carcinoma.
Measured: Day 0
Number of Circulatory Tumor Cells with the tumor number of HepatoCellular Carcinoma.
Measured: Day 0
Number of Circulatory Tumor Cells withBarcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.
Measured: Day 0
Number of cfDNA amount with the tumor size of HepatoCellular Carcinoma.
Measured: Day 0
Number of cfDNA amount with the tumor number of HepatoCellular Carcinoma.
Measured: Day 0
Number of cfDNA amount with the Barcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start15 May 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162198
- Sponsor's protocol ID
- ILBS-HCC-03
- Status last verified
- Oct 2019
- First submitted
- 20 Apr 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT03162198
- Acronym / sponsor ID
- ILBS-HCC-03
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 22 May 2017 (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.
All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for inclusion.Based on the previous years data of HCC patients admitted to ILBS.
Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the Study of Liver Disease (AASLD) guidelines (details in appendix1).
Age and gender matched patients with cirrhosis, but without HCC, seen during the same study period will serve as controls.
Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted. Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis with HCC | – | Other: Cirrhosis with HCC |
| Cirrhosis without HCC | – | Other: Cirrhosis without HCC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Proven cirrhosis with HCC proven by standard radiological criteria within last 1 month. * Proven cirrhosis with no HCC on dynamic CT and/or dynamic MRI done within last 1 month.
Key inclusion criteria (4 listed)
- Age between 18-70 years.
- Proven cirrhosis (Defined in appendix 1).
- HCC proven by standard radiological criteria within last 1-month (For Cases)
- No HCC on dynamic CT and/or dynamic MRI (protocol defined in appendix 1) done within last 1 month (For Control Group).
Key exclusion criteria (10 listed)
- Previous biopsy or FNA of the tumor.
- Previous invasive radiological procedures TACE/RFA.
- Previous or ongoing chemotherapy or biological therapy.
- Previous liver resection or transplant.
- Segmental / main PV thrombosis.
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 |
|---|---|---|
| Cirrhosis with HCCCirrhosis with Hepatocellular Carcinoma | Other | Cirrhosis with HCC |
| Cirrhosis without HCCCirrhosis without Hepatocellular Carcinoma | Other | Cirrhosis without HCC |
Primary outcome
Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)
Time frame: Day 0
Number of cell-free DNA (cfDNA) in cirrhotic patients with hepatocellular carcinoma (HCC)
Time frame: Day 0
8 secondary outcomes
Number of Circulating Tumor Cells in the peripheral blood of cirrhotic patients in both groups
Time frame: Day 0
To study the difference in amount of cfDNA in the peripheral blood of cirrhotic patients with and without HCC.
Time frame: Day 0
Number of Circulatory Tumor Cells with the tumor size of HepatoCellular Carcinoma.
Time frame: Day 0
Number of Circulatory Tumor Cells with the tumor number of HepatoCellular Carcinoma.
Time frame: Day 0
Number of Circulatory Tumor Cells withBarcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.
Time frame: Day 0
Number of cfDNA amount with the tumor size of HepatoCellular Carcinoma.
Time frame: Day 0
Number of cfDNA amount with the tumor number of HepatoCellular Carcinoma.
Time frame: Day 0
Number of cfDNA amount with the Barcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.
Time frame: Day 0
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 23 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatocellular Carcinoma, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 4 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 23 Oct 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 India. 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?
Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC) (time frame: Day 0). The study lists 2 primary outcomes in all. 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 23 Oct 2019.