Real-World Clinical Study for Malignant Tumor-Induced Cac... | NCT07008248

Studies
Real-World Clinical Study for Malignant Tumor-Induced Cachexia

NCT07008248

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Withdrawn

Last Update Posted

Aug 8, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company strategy adjustment

Expanded Access Info

Start Date

Oct 15, 2024Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 26, 2025

First Submission Date that Met QC Criteria

Jun 4, 2025

First Posted Date

Jun 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2025

Last Update Posted Date

Aug 8, 2025Actual

Name	Class
Xuzhou Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The value of weight increase compared to the baseline		through the observation period，an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Cachexia patients with malignant tumors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University		Xuzhou	Jiangsu	221000	China