Real-World Clinical Study for Malignant Tumor-Induced Cachexia

NCT07008248 | Withdrawn

• 1 other identifier: Megaxia RWS
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The value of weight increase compared to the baseline

  through the observation period，an average of 1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cachexia patients with malignant tumors

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Xuzhou Central Hospital: collaborator

Study Sites (1)

Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 6, 2025
• Study Start: October 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2024-10

Locations

CN (1)