Chronic Liver Disease (CLD)NCT06868394
Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy
An observational study of Chronic Liver Disease (CLD) and Cancer, run by Suez Canal University at 1 site in Egypt.
Trial summary
Cancer survivors are at a high risk to develop second primary malignancy (SPM) which constitutes a serious threat for them. Radiotherapy is the cornerstone for the management of many cancers as a locoregional treatment modality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Liver Disease (CLD), Cancer, Liver Fibrosis
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20,846 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2010to 30 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Using the Surveillance, Epidemiology and End Results (SEER) database (17 Registries, 2000-2021, November 2023 Submission), maintained by the National Cancer Institute (NCI) containing a population-based cancer incidence and survival data from 17 registries covering approximately 28% of the U.S. population to extract the data of cancer patients with chronic liver disease diagnosed from 2010 to 2021. Patients were classified according to fibrosis severity using the Ishak fibrosis score: F0-F4 (no to moderate fibrosis) and F5-F6 (advanced or severe cirrhosis) from 2010 to 2021. Patients were stratified based on previous radiotherapy exposure into two groups; who received radiotherapy including beam radiation, radioactive implants, radioisotopes, combinations, or unspecified radiotherapy methods and patients who received no radiotherapy.
Who may be able to join
- Cancer patients were classified according to fibrosis severity using the Ishak fibrosis score: F0-F4 (no to moderate fibrosis) and F5-F6 (advanced or severe cirrhosis) from 2010 to 2021.
Who cannot join
- Patients with unknown radiotherapy history or unknown fibrosis score or missing age data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy: a SEER Database Analysis 2010-2021
Cancer survivors are at a high risk to develop second primary malignancy (SPM) which constitutes a serious threat for them. Radiotherapy is the cornerstone for the management of many cancers as a locoregional treatment modality. Due to the low liver tolerance, cirrhotic patients are at a high risk of developing radiation-induced liver toxicities despite the modern safe radiation delivery techniques. Radiation damages cells through direct energy deposition and reactive free radical generation. Recent studies demonstrated a potential risk of SPMs following radiotherapy with further investigations for strategies to decrease radiation-induced SPMs. However, it is insufficiently addressed if developing liver SPMs is a serious adverse event following radiotherapy for cirrhotic patients. The aim of this study was to quantitatively assess the risk of gastrointestinal (GI) and liver SPMs following radiotherapy in patients with chronic liver disease.
Read the detailed description
The SEER.stat software version 8.4.3 was used to obtain and analyze the data of patients with chronic liver disease diagnosed from 2010 to 2021. Using Ishak fibrosis score: F0-4 no to moderate fibrosis and F5-6 advanced or severe cirrhosis. patients were subgrouped according to the history of receiving radiotherapy for prior cancer treatment in two groups and excluded patients with unknown radiotherapy administration history. An MP-SIR session was used to calculate the Standardized Incidence Ratio (SIR) as Observed/Expected (O/E) with 95% confidence interval (CI). Significance was achieved at 0.05.
- Conditions
- Chronic Liver Disease (CLD), Cancer, Liver Fibrosis
- Being tested
- radiotherapy, No intervention
- Keywords
- chronic liver, SEER, Liver fibrosis, ISHAK score
- Medical subject headings
- Neoplasms, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
The impact of previous radiotherapy exposure was studied on developing second primary malignancies.
No interventionOther
This group received no radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with no to moderated liver fibrosis (ISHAK 0-4) | They were subgrouped according to previous history of radiotherapy exposure into two groups. Both groups were followed up for 10 years to assess the risk of second primary malignancies. The investigators retrospectively analyzed the data. Receives: Radiation: radiotherapy; Other: No intervention | |
| Patients with advanced or severe liver fibrosis (ISHAK 5-6) | They were subgrouped according to previous history of radiotherapy exposure into two groups. Both groups were followed up for 10 years to assess the risk of second primary malignancies. The investigators retrospectively analyzed the data. Receives: Radiation: radiotherapy; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The standardized incidence ratio and excess risk of developing gastrointestinal and liver second primary malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 0-4)
The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the Excess absolute risk for multiple primary gastrointestinal and liver malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 0-4)
Measured: from Jan, 2010 till Dec, 2021
The standardized incidence ratio and excess risk of developing gastrointestinal and liver second primary malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 5-6)
The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the Excess absolute risk for multiple primary gastrointestinal and liver malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 5-6)
Measured: from Jan, 2010 till Dec, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2010
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease (CLD)Studies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa salama ibrahim, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868394
- Sponsor's protocol ID
- H2730
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 11 Mar 2025
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy: a SEER Database Analysis 2010-2021
- ClinicalTrials.gov ID
- NCT06868394
- Acronym / sponsor ID
- H2730
- Conditions
- Chronic Liver Disease (CLD), Cancer, Liver Fibrosis
- Keywords
- chronic liver, SEER, Liver fibrosis, ISHAK score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,846 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 11 Mar 2025 (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.
Cancer survivors are at a high risk to develop second primary malignancy (SPM) which constitutes a serious threat for them. Radiotherapy is the cornerstone for the management of many cancers as a locoregional treatment modality. Due to the low liver tolerance, cirrhotic patients are at a high risk of developing radiation-induced liver toxicities despite the modern safe radiation delivery techniques. Radiation damages cells through direct energy deposition and reactive free radical generation. Recent studies demonstrated a potential risk of SPMs following radiotherapy with further investigations for strategies to decrease radiation-induced SPMs. However, it is insufficiently addressed if developing liver SPMs is a serious adverse event following radiotherapy for cirrhotic patients. The aim of this study was to quantitatively assess the risk of gastrointestinal (GI) and liver SPMs following radiotherapy in patients with chronic liver disease.
Detailed description
The SEER.stat software version 8.4.3 was used to obtain and analyze the data of patients with chronic liver disease diagnosed from 2010 to 2021. Using Ishak fibrosis score: F0-4 no to moderate fibrosis and F5-6 advanced or severe cirrhosis. patients were subgrouped according to the history of receiving radiotherapy for prior cancer treatment in two groups and excluded patients with unknown radiotherapy administration history. An MP-SIR session was used to calculate the Standardized Incidence Ratio (SIR) as Observed/Expected (O/E) with 95% confidence interval (CI). Significance was achieved at 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with no to moderated liver fibrosis (ISHAK 0-4) | – | Radiation: radiotherapy, Other: No interventionThey were subgrouped according to previous history of radiotherapy exposure into two groups. Both groups were followed up for 10 years to assess the risk of second primary malignancies. The investigators retrospectively analyzed the data. |
| Patients with advanced or severe liver fibrosis (ISHAK 5-6) | – | Radiation: radiotherapy, Other: No interventionThey were subgrouped according to previous history of radiotherapy exposure into two groups. Both groups were followed up for 10 years to assess the risk of second primary malignancies. The investigators retrospectively analyzed the data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Using the Surveillance, Epidemiology and End Results (SEER) database (17 Registries, 2000-2021, November 2023 Submission), maintained by the National Cancer Institute (NCI) containing a population-based cancer incidence and survival data from 17 registries covering approximately 28% of the U.S. population to extract the data of cancer patients with chronic liver disease diagnosed from 2010 to 2021. Patients were classified according to fibrosis severity using the Ishak fibrosis score: F0-F4 (no to moderate fibrosis) and F5-F6 (advanced or severe cirrhosis) from 2010 to 2021. Patients were stratified based on previous radiotherapy exposure into two groups; who received radiotherapy including beam radiation, radioactive implants, radioisotopes, combinations, or unspecified radiotherapy methods and patients who received no radiotherapy.
Key inclusion criteria (1 listed)
- Cancer patients were classified according to fibrosis severity using the Ishak fibrosis score: F0-F4 (no to moderate fibrosis) and F5-F6 (advanced or severe cirrhosis) from 2010 to 2021.
Key exclusion criteria (1 listed)
- Patients with unknown radiotherapy history or unknown fibrosis score or missing age data
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 |
|---|---|---|
| radiotherapyThe impact of previous radiotherapy exposure was studied on developing second primary malignancies. | Radiation | Patients with advanced or severe liver fibrosis (ISHAK 5-6), Patients with no to moderated liver fibrosis (ISHAK 0-4) |
| No interventionThis group received no radiotherapy | Other | Patients with advanced or severe liver fibrosis (ISHAK 5-6), Patients with no to moderated liver fibrosis (ISHAK 0-4) |
Primary outcome
The standardized incidence ratio and excess risk of developing gastrointestinal and liver second primary malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 0-4)
Time frame: from Jan, 2010 till Dec, 2021
The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the Excess absolute risk for multiple primary gastrointestinal and liver malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 0-4)
The standardized incidence ratio and excess risk of developing gastrointestinal and liver second primary malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 5-6)
Time frame: from Jan, 2010 till Dec, 2021
The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the Excess absolute risk for multiple primary gastrointestinal and liver malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 5-6)
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 11 Mar 2025.
- 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 Chronic Liver Disease (CLD) and Cancer, run by Suez Canal 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 1 inclusion and 1 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 11 Mar 2025. 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?
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?
The standardized incidence ratio and excess risk of developing gastrointestinal and liver second primary malignancies following radiotherapy exposure in patients with chronic liver disease (ISHAK 0-4) (time frame: from Jan, 2010 till Dec, 2021). 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 11 Mar 2025.