Hepatocellular CarcinomaNCT03869151
Pretreatment Lymphocyte Monocyte Ratio on Outcome HCC Patients
An observational study of Hepatocellular Carcinoma, run by Amany Aboalenen Amin.
Trial summary
To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CBC
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2019to 31 Mar 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular carcinoma patients
Who may be able to join
- Patients with child A Hepatocellular carcinoma.
Who cannot join
- Patients with child C Hepatocellular carcinoma.
- Patients with heart failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Pretreatment Lymphocyte to Monocyte Ratio on Clinical Outcome for Patient With HCC
To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC).
Read the detailed description
The exact molecular mechanisms responsible for the prognostic impact of lymphocyte monocyte ratio in Heatocellular carcinoma are unclear.It has been suggested that cross-talk between the inflammatory response and tumor progression play a critical role in the initiation and progression of Heatocellular carcinoma. In the tumor microenvironment, inflammatory infiltrates have a large influence on the biological behavior of Heatocellular carcinoma.
Tumor-infiltrating lymphocytes, as representative component of the immune microenvironment ,are implicated in several stages of Heatocellular carcinoma progression, and Tumor-infiltrating lymphocytes phenotypes may be a predictor for favorable prognosis.
Conversely, low lymphocyte counts might result in an insufficient immunological reaction, which lead to inferior survival in multiple cancers.
Monocytes infiltrating tumor tissue are also involved in Heatocellular carcinoma development and progression. Activated monocytes in Heatocellular carcinoma micro environments can trigger and polarize T-cell responses and facilitate inflammation-induced tumor development.
Tumor-associated macrophages are derived from circulating monocytes. Tumor-associated macrophages can accelerate Heatocellular carcinoma cell proliferation,tumor-associated angiogenesis, and metastasis. Several studies showed that high infiltration of Tumor-associated macrophages predicted decreased survival in various cancers.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CBC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCDiagnostic test
lymphocyte and monocyte count
What is being measured
The primary outcome is the main question the study is designed to answer.
increased over all survival
Elevated pretreatment lymphocyte monocyte ratio may be a favorable prognostic factor for clinical outcomes in patients with hepatocellular carcinoma.
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 posted11 Mar 2019
- Study start5 Apr 2019 (estimated)
- Primary completion5 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
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.
- 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
- 1 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Amany Aboalenen Amin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Aboalenen Amin, Assiut University
- Investigators
- taha mahran, MD, Study chair, Assiut Universityola abdelfatah, MD, Study chair, Assiut Universityaml ebraheem, MD, Study director, Assiut Universityamany amin, master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869151
- Sponsor's protocol ID
- 17200000
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pretreatment Lymphocyte to Monocyte Ratio on Clinical Outcome for Patient With HCC
- ClinicalTrials.gov ID
- NCT03869151
- Acronym / sponsor ID
- 17200000
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Amany Aboalenen AminUniversity, hospital or other
- Study start
- 5 Apr 2019 (estimated)
- Primary completion
- 5 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 11 Mar 2019 (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.
To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC).
Detailed description
The exact molecular mechanisms responsible for the prognostic impact of lymphocyte monocyte ratio in Heatocellular carcinoma are unclear.It has been suggested that cross-talk between the inflammatory response and tumor progression play a critical role in the initiation and progression of Heatocellular carcinoma. In the tumor microenvironment, inflammatory infiltrates have a large influence on the biological behavior of Heatocellular carcinoma.
Tumor-infiltrating lymphocytes, as representative component of the immune microenvironment ,are implicated in several stages of Heatocellular carcinoma progression, and Tumor-infiltrating lymphocytes phenotypes may be a predictor for favorable prognosis.
Conversely, low lymphocyte counts might result in an insufficient immunological reaction, which lead to inferior survival in multiple cancers.
Monocytes infiltrating tumor tissue are also involved in Heatocellular carcinoma development and progression. Activated monocytes in Heatocellular carcinoma micro environments can trigger and polarize T-cell responses and facilitate inflammation-induced tumor development.
Tumor-associated macrophages are derived from circulating monocytes. Tumor-associated macrophages can accelerate Heatocellular carcinoma cell proliferation,tumor-associated angiogenesis, and metastasis. Several studies showed that high infiltration of Tumor-associated macrophages predicted decreased survival in various cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carcinoma patients
Key inclusion criteria (1 listed)
- Patients with child A Hepatocellular carcinoma.
Key exclusion criteria (2 listed)
- Patients with child C Hepatocellular carcinoma.
- Patients with heart failure
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 |
|---|---|---|
| CBClymphocyte and monocyte count | Diagnostic test | – |
Primary outcome
increased over all survival
Time frame: 1 year
Elevated pretreatment lymphocyte monocyte ratio may be a favorable prognostic factor for clinical outcomes in patients with hepatocellular carcinoma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
taha mahran, MD study chair
Assiut University
ola abdelfatah, MD study chair
Assiut University
aml ebraheem, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Amany Aboalenen Amin.
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 1 inclusion and 2 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact amany Amin, master (+201093930042, dr.ma777moud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increased over all survival (time frame: 1 year). 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 Apr 2019.