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

Cachexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04594863
• Other study ID #: ZS-2525
• Status: Not yet recruiting
• Start date: November 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2020
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, MD
• Phone: +8613801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
China	Peking Union Medical College Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Argilés JM, Busquets S, Stemmler B, López-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014 Nov;14(11):754-62. doi: 10.1038/nrc3829. Epub 2014 Oct 9. Review. — View Citation

Fearon KC, Glass DJ, Guttridge DC. Cancer cachexia: mediators, signaling, and metabolic pathways. Cell Metab. 2012 Aug 8;16(2):153-66. doi: 10.1016/j.cmet.2012.06.011. Epub 2012 Jul 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIRT-6 expression	SIRT-6 expression tested by ELISA	4 months