The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04594863
Collaborator
(none)
100
1
7
14.4

Study Details

Study Description

Brief Summary

The study is going to recruit patients with gastrointestinal cancer, collect clinical data and peripheral blood sample and possible fat samples. The expression of SIRT-6 in peripheral blood will be tested and connect with different status of cachexia of the patients. A mathematical model of the relationship between cachexia classification and SIRT-6 expression is going to constructed as anticipated.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    At the start of cancer develop, not all patients with gastrointestinal cancer manifest cachexia, it may be associated with SIRT-6 expression. This study will collect and test the peripheral blood sample of patients, use it as an important indicator of the degree of cachexia, and provide references for clinical drug intervention, prognosis and dietary intervention for cachexia patients. If possible, fat sample of the patients will be collected during surgery, and the adipose progenitor cells will be cultured to find the key target proteins by detecting differences in protein expression, changes in protein modification levels, and protein interactions.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer
    Anticipated Study Start Date :
    Nov 1, 2020
    Anticipated Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    Jun 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    cachexia

    patients suffering from cachexia recently

    no cachexia

    patients are not suffering from cachexia recently

    Outcome Measures

    Primary Outcome Measures

    1. SIRT-6 expression [4 months]

      SIRT-6 expression tested by ELISA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age between 18 and 90 years old, unlimited gender;

    2. Patients who are diagnosed with gastrointestinal cancer for the first time and are planning to undergo further treatment;

    3. Volunteer to participate and sign the informed consent form.

    Exclusion Criteria:
    1. Women who are pregnant or lactate;

    2. Patients with severe metabolic diseases; combined with cardiac function, liver and kidney dysfunction, acute myocardial infarction and acute stroke in the past 3 months , COPD acute onset respiratory failure and other serious medical diseases and patients who need hormone therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospita Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Study Director: Kang Yu, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04594863
    Other Study ID Numbers:
    • ZS-2525
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Oct 20, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 20, 2020