Early Diagnosis of Gastric Cancer Cachexia

February 18, 2024 updated by: Xijing Hospital

Clinical Value of Tumor Cell-derived Exosomal miRNA in Early Diagnosis of Gastric Cancer Cachexia

Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In gastric cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Fourth Military Medical University
        • Contact:
          • Jipeng Li
          • Phone Number: +86-029-84771533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The research object is patients with confirmed gastric cancer.According to diagnostic criteria, patients are divided into cachexia group and non-cachexia group.

Description

Inclusion Criteria:

  1. Patients with gastric cancer diagnosed by histopathology or cytopathology
  2. Complete clinical and pathological data
  3. No previous or current mental illness or disturbance of consciousness

Exclusion Criteria:

  1. With multiple tumors or other malignant diseases
  2. Combined with other chronic wasting and metabolic diseases
  3. Past patients with non-tumor cachexia
  4. People with mental illness or unable to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric cancer patients with non-cachexia
Other: cachexia
Cachexia mainly manifests as weight loss. 1)weight loss >5% over past 6 months. 2)BMI<20 and any degree of weight loss >2%. 3)Appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss >2%.
Gastric cancer patients with cachexia
Other: cachexia
Cachexia mainly manifests as weight loss. 1)weight loss >5% over past 6 months. 2)BMI<20 and any degree of weight loss >2%. 3)Appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss >2%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: six months
Calculate BMI based on changes in body weight in the past six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20212018-F-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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