Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20846 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2021-12-30

Brief Summary

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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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Detailed Description

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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

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Chronic Liver Disease (CLD) Cancer Liver Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

radiotherapy

Intervention Type RADIATION

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

No intervention

Intervention Type OTHER

This group received no radiotherapy

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.

radiotherapy

Intervention Type RADIATION

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

No intervention

Intervention Type OTHER

This group received no radiotherapy

Interventions

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radiotherapy

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

Intervention Type RADIATION

No intervention

This group received no radiotherapy

Intervention Type OTHER

Eligibility Criteria

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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.