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Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy

Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy: a SEER Database Analysis 2010-2021

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06868394
Enrollment
20846
Registered
2025-03-11
Start date
2010-01-01
Completion date
2021-12-30
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chronic Liver Disease (CLD), Liver Fibrosis

Keywords

chronic liver, SEER, Liver fibrosis, ISHAK score

Brief 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. 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.

Interventions

RADIATIONradiotherapy

The impact of previous radiotherapy exposure was studied on developing second primary malignancies.

OTHERNo intervention

This group received no radiotherapy

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients with unknown radiotherapy history or unknown fibrosis score or missing age data

Design outcomes

Primary

MeasureTime frameDescription
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)from Jan, 2010 till Dec, 2021The 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)from Jan, 2010 till Dec, 2021The 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026