NCT06868394

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
• Phase: —
• Study type: Observational
• Enrollment: 20,846 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease (CLD)
• Cancer
• Liver Fibrosis

Interventions

Type	Name	Description
RADIATION	radiotherapy	The impact of previous radiotherapy exposure was studied on developing second primary malignancies.
OTHER	No intervention	This group received no radiotherapy

Timeline

• Start date: 2010-01-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2025-03-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: Egypt