Gender Differences in Gastric Cancer Care and Its Adherence to Guidelines in Germany

NCT06902337 | Active Not Recruiting

• 2 other identifiers: MaGen (01VSF24051)01VSF24051
• Study Type: observational
• Target: 75,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, co-morbidities, treatment approaches, and survival outcomes. This study aims to explore gender-specific variations in clinical management and their impact on mortality, complications, and survival rates in gastric carcinoma patients in Germany. Methods: This nationwide, retrospective cohort study will analyze data from the German Diagnosis-Related Group statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of gender differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities, and postoperative outcomes. The analysis will investigate whether gender influences tumor characteristics, access to treatment, and therapy effectiveness. Statistical methods such as descriptive analysis, regression models, and survival analysis will be applied to identify gender-related variations in diagnosis, treatment, and outcomes. Discussion: By identifying potential gender disparities in diagnosis, treatment, and outcomes, the findings may inform revisions to clinical guidelines and support the development of more personalized treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualized, sex-sensitive medical practices.

Conditions

Gastric Adenocarcinoma

Keywords

Gastric cancer; Sex differences; Clinicopathological characteristics; Treatment; Mortality; Survival; Treatment guidelines; Administrative routine data; Cancer registry data

Outcome Measures

Primary Outcomes (2)

• DRG statistic: in-hospital mortality

  Death in hospital after treatment in days

  2017-2021

• Cancer registry: 1 and 3 year survival

  Survival after diagnosis date in months

  2017-2021

Study Arms (1)

Patients with gastric adenocarcinoma

Gastric carcinoma (ICD-10-GM C16) Patients with gastric carcinoma in the years 2017-2021 in Germany, minimum age 18 years

Eligibility Criteria

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

Study Population

A) Cases from the DRG statistics for the years 2017-2021 with inclusion criteria minimum age 18 years, full inpatient hospital treatment in the years 2017-2021, ICD-10-GM code C16, C16.1 - C16.9 B) Cases recorded in a clinical cancer registry from 2017-2021 with ICD-10-GM code C16, C16.1-C16.9

You may qualify if:

• Gastric adenocarcinoma ICD-10-GM code C16, C16.1 - C16.9

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead

Study Sites (1)

Medical School Brandenburg

Brandenburg, Brandenburg, 14770, Germany

Location

Related Publications (1)

• Weber U, Kress L, Hunger R, Schildberg C, Mantke R. Gender differences in gastric cancer care and its adherence to guidelines in Germany (MaGen): protocol for an observational retrospective cohort study with administrative routine and cancer registry data from 2017 to 2021. BMJ Open. 2026 Feb 2;16(2):e103467. doi: 10.1136/bmjopen-2025-103467.

  PMID: 41628928 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of Surgery at University Hospital Brandenburg an der Havel

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 30, 2025
• Study Start: July 31, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)