Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy

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.

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Key information

Conditions

Chronic Liver Disease (CLD) Cancer Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Liver Fibrosis Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

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

No intervention

Other

This group received no radiotherapy

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2021
Study completion: 2021
First posted: Mar 11, 2025
Registry last updated: Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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