NCT06277986

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2022

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 26, 2024

Status Verified

January 1, 2024

Enrollment Period

3.3 years

First QC Date

January 16, 2022

Last Update Submit

February 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • BMI

    Calculate BMI based on changes in body weight in the past six months

    six months

Study Arms (2)

Gastric cancer patients with non-cachexia

Other: cachexia

Gastric cancer patients with cachexia

Other: cachexia

Interventions

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 cachexiaGastric cancer patients with non-cachexia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Military Medical University

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Cachexia

Interventions

dermcidin

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2022

First Posted

February 26, 2024

Study Start

June 1, 2021

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

February 26, 2024

Record last verified: 2024-01

Locations