Real-World Clinical Study for Malignant Tumor-Induced Cachexia

Recruiting

• Conditions: Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia; Multicenter Observational Study

• Registration Number: NCT07008248
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

This study is a non-interventional, multicenter observational study, aiming to assess the clinical characteristics and treatment outcomes of malignant tumor cachexia. The study is mainly divided into two cohorts:

Retrospective Cohort: This cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study. It involves the retrospective collection and analysis of clinical data.

Prospective Cohort: This cohort includes patients who are diagnosed with cachexia after the start of this study. Data will be prospectively collected and analyzed during their subsequent diagnosis and treatment process.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Aged 18 years or older (including 18 years).
• Malignant tumor confirmed by histology or cytology (both malignant solid tumors and malignant hematologic tumors are eligible for enrollment).
• Meeting the Fearon diagnostic criteria for cachexia.
• Life expectancy of ≥2 months (for the prospective cohort only).
• Able to sign the informed consent form (waiver of informed consent for the retrospective cohort).

Exclusion Criteria

Retrospective Cohort:

• Missing gender information.
• Missing date of birth or age information.
• Lack of any treatment or follow-up information after the date of meeting the diagnostic criteria for cachexia.

Prospective Cohort: (Patients with any of the following are not eligible for enrollment in this study)

• Patients who are unable to receive any treatment for any reason.
• Patients who cannot undergo at least one follow-up.
• Patients whom the investigator deems unsuitable for participation in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The value of weight increase compared to the baseline	through the observation period，an average of 1 year

Trial Locations

Locations (1)

Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China