Carcinoma, HepatocellularNCT06629857
A Cross Sectional Study Evaluating the Mean Levels of Alpha Fetoprotein in Patients of Hepatocellular Carcinoma and Its Correlates in Pakistan
An observational study of Carcinoma, Hepatocellular, run by Darul Sehat Hospital at 1 site in Pakistan.
Trial summary
This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. Read more about this study
- Who is it for?
- Ages 27 to 80 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- How many people
- 94 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2022to 1 Mar 2023
- How long will I take part?
- 6 Months
- 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 27 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of a total of 94 adult patients diagnosed with hepatocellular carcinoma (HCC) who are receiving care at Dar ul Sehat Hospital, Karachi, Pakistan. Participants will be recruited from outpatient, emergency, and inpatient departments. Eligible individuals will be aged between 27 to 80 years and must have been diagnosed with HCC within the last three months, confirmed by relevant investigations. The study aims to reflect a diverse population that includes various tumor sizes and underlying liver disease etiologies, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis, and cirrhosis. Patients will be excluded if they have elevated alpha-fetoprotein levels due to tumors other than HCC or have secondary liver metastases from other primary sites. This approach ensures that the findings are specific to HCC and its correlates, aiding in the assessment of AFP levels in this population.
Who may be able to join
- Aged between 27 to 80 years.
- Diagnosed with hepatocellular carcinoma (HCC) within the last three months.
- Diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy).
- Able to provide informed consent.
Who cannot join
- Elevated alpha-fetoprotein levels due to tumors other than HCC.
- Presence of secondary liver metastases from other primary sites.
- Any significant comorbid conditions that could interfere with study assessments.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Correlation of Alpha-Fetoprotein in Hepatocellular Carcinoma: a Cross-Sectional Study from Southeast Asia
This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. By analyzing data from 94 patients, the study seeks to identify factors that influence AFP levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches.
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular carcinoma (HCC), Alpha-fetoprotein (AFP) levels, Liver cancer biomarkers, Tumor size and AFP correlation, Hepatitis B and C in liver cancer, Non-alcoholic steatohepatitis (NASH), AFP as a diagnostic tool, Liver tumor progression markers
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: HCC Patients with Elevated AFP Levels Description: This group includes patients diagnosed | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Alpha-Fetoprotein (AFP) Levels in HCC Patients
Measured: Baseline measurement at time of diagnosis.
Secondary outcomes (1)
Correlation Between AFP Levels and Tumor Size
Measured: At baseline (upon diagnosis).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Oct 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
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.
- 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
- Cross-sectional
- Enrolment
- 94 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Darul Sehat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Abbasi, Jinnah Sindh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629857
- Sponsor's protocol ID
- M-000037/22
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlation of Alpha-Fetoprotein in Hepatocellular Carcinoma: a Cross-Sectional Study from Southeast Asia
- ClinicalTrials.gov ID
- NCT06629857
- Acronym / sponsor ID
- M-000037/22
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular carcinoma (HCC), Alpha-fetoprotein (AFP) levels, Liver cancer biomarkers, Tumor size and AFP correlation, Hepatitis B and C in liver cancer, Non-alcoholic steatohepatitis (NASH), AFP as a diagnostic tool, Liver tumor progression markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Darul Sehat HospitalUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Oct 2024 (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.
This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. By analyzing data from 94 patients, the study seeks to identify factors that influence AFP levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: HCC Patients with Elevated AFP Levels Description: This group includes patients diagnosed | – | – |
Who may qualify
- Ages
- 27 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of a total of 94 adult patients diagnosed with hepatocellular carcinoma (HCC) who are receiving care at Dar ul Sehat Hospital, Karachi, Pakistan. Participants will be recruited from outpatient, emergency, and inpatient departments. Eligible individuals will be aged between 27 to 80 years and must have been diagnosed with HCC within the last three months, confirmed by relevant investigations. The study aims to reflect a diverse population that includes various tumor sizes and underlying liver disease etiologies, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis, and cirrhosis. Patients will be excluded if they have elevated alpha-fetoprotein levels due to tumors other than HCC or have secondary liver metastases from other primary sites. This approach ensures that the findings are specific to HCC and its correlates, aiding in the assessment of AFP levels in this population.
Key inclusion criteria (4 listed)
- Aged between 27 to 80 years.
- Diagnosed with hepatocellular carcinoma (HCC) within the last three months.
- Diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy).
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- Elevated alpha-fetoprotein levels due to tumors other than HCC.
- Presence of secondary liver metastases from other primary sites.
- Any significant comorbid conditions that could interfere with study assessments.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Alpha-Fetoprotein (AFP) Levels in HCC Patients
Time frame: Baseline measurement at time of diagnosis.
1 secondary outcome
Correlation Between AFP Levels and Tumor Size
Time frame: At baseline (upon diagnosis).
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 8 Oct 2024.
- 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.
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 Carcinoma, Hepatocellular, run by Darul Sehat Hospital at 1 site in Pakistan.
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 4 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 8 Oct 2024. 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 Pakistan. 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?
Mean Alpha-Fetoprotein (AFP) Levels in HCC Patients (time frame: Baseline measurement at time of diagnosis.). 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 8 Oct 2024.