Role of Serum Regucalcin in Diagnosis of HCCNCT03206866
Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma
An observational study of Role of Serum Regucalcin in Diagnosis of HCC, run by Mansoura University at 1 site in Egypt.
Trial summary
Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Role of Serum Regucalcin in Diagnosis of HCC
- What is being tested?
- serum regucalcin antibody
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2016to 30 Dec 2017
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients will be subjected to the following: * Detailed History taking. * Physical examination. * Routine laboratory investigations essential for diagnosis and follow up of patients including: 1. Complete blood count (CBC). 2. Chemistry profile: serum bilirubin-serum albumin-SGPT-SGOT. 3. serum regucalcin(SMP30) antibodies using ELISA 4. AFP level. * Radiological assessment: US, Triphasic CT to assess (tumor site, size, numbers, nodal metastases, distal metastases, portal vein invasion..)
Who may be able to join
- Newly diagnosed cases of HCC (be based on NCCN guidelines triphasic CT and AFP or liver biopsy)
- Adult patients
- Both genders are eligible.
- Informed consent obtained from subject or subject's legal representative
Who cannot join
- Patient with other malignancies.
- Patients with advanced comorbidities except for renal failure.
- Prior chemotherapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology Center Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
maha zaafarany, professor, 01001996798
sameh samaa, professor, 01001009510
About this study
Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or therapeutic targets.
SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identified from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular carcinoma associated antigens [4]
Serum antibody response to SMP30 in various patients using the methods of Western-blot and ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in the one with alpha-fetoprotein (AFP) negative
- Being tested
- serum regucalcin antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum regucalcin antibodyDiagnostic test
serum regucalcin antibody
| Study group | Role | What they receive |
|---|---|---|
| patients with HCC | Not described Receives: Diagnostic Test: serum regucalcin antibody | |
| patients with hepatitis C Ab positive | Not described Receives: Diagnostic Test: serum regucalcin antibody | |
| patients with hepatitis C Ab negative | Not described Receives: Diagnostic Test: serum regucalcin antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum regucalcin in HCC patients
This work aims to assess serum regucalcin antibodies level using ELISA in HCC patients to:
- evaluate its potential role as biomarker in diagnosis.
- evaluate potential associations of the presence of serum regucalcin antibody with HCC patients' clinico-epidemiological parameters.
Measured: 1-12-2016 to 1-12-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start30 Dec 2016
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Serum Regucalcin in Diagnosis of HCCStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Other
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed_Elalfy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206866
- Sponsor's protocol ID
- SMP30
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03206866
- Acronym / sponsor ID
- SMP30
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 2 Jul 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.
Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or therapeutic targets.
SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identified from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular carcinoma associated antigens [4]
Serum antibody response to SMP30 in various patients using the methods of Western-blot and ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in the one with alpha-fetoprotein (AFP) negative
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with HCC | – | Diagnostic Test: serum regucalcin antibody |
| patients with hepatitis C Ab positive | – | Diagnostic Test: serum regucalcin antibody |
| patients with hepatitis C Ab negative | – | Diagnostic Test: serum regucalcin antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be subjected to the following: * Detailed History taking. * Physical examination. * Routine laboratory investigations essential for diagnosis and follow up of patients including: 1. Complete blood count (CBC). 2. Chemistry profile: serum bilirubin-serum albumin-SGPT-SGOT. 3. serum regucalcin(SMP30) antibodies using ELISA 4. AFP level. * Radiological assessment: US, Triphasic CT to assess (tumor site, size, numbers, nodal metastases, distal metastases, portal vein invasion..)
Key inclusion criteria (4 listed)
- Newly diagnosed cases of HCC (be based on NCCN guidelines triphasic CT and AFP or liver biopsy)
- Adult patients
- Both genders are eligible.
- Informed consent obtained from subject or subject's legal representative
Key exclusion criteria (3 listed)
- Patient with other malignancies.
- Patients with advanced comorbidities except for renal failure.
- Prior chemotherapy
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 |
|---|---|---|
| serum regucalcin antibodyserum regucalcin antibody | Diagnostic test | patients with HCC, patients with hepatitis C Ab negative, patients with hepatitis C Ab positive |
Primary outcome
serum regucalcin in HCC patients
Time frame: 1-12-2016 to 1-12-2017
This work aims to assess serum regucalcin antibodies level using ELISA in HCC patients to: * evaluate its potential role as biomarker in diagnosis. * evaluate potential associations of the presence of serum regucalcin antibody with HCC patients' clinico-epidemiological parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
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 Role of Serum Regucalcin in Diagnosis of HCC, run by Mansoura University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Jul 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum regucalcin in HCC patients (time frame: 1-12-2016 to 1-12-2017). 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 2 Jul 2017.