Chronic Liver Disease and Radiation-induced Second Primary Liver Malignancy

NCT06868394 | Completed

• 1 other identifier: H2730
• Study Type: observational
• Target: 20,846
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease (CLD); Cancer; Liver Fibrosis

Keywords

chronic liver; SEER; Liver fibrosis; ISHAK score

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  from Jan, 2010 till Dec, 2021

Study Arms (2)

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.

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.

Radiation: radiotherapy; Other: No intervention

Interventions

radiotherapy RADIATION

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

Patients with advanced or severe liver fibrosis (ISHAK 5-6); Patients with no to moderated liver fibrosis (ISHAK 0-4)

No intervention OTHER

This group received no radiotherapy

Patients with advanced or severe liver fibrosis (ISHAK 5-6); Patients with no to moderated liver fibrosis (ISHAK 0-4)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Neoplasms; Liver Cirrhosis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician of gastroenterology

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2010
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

EG (1)