Clinical trial NCT04594863: The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer
Official title: The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cachexia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with gastrointestinal cancer for the first time without any chemotherapy or radiotherapy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SIRT-6 expression
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospita
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Kang Yu
role: STUDY_DIRECTOR
References:
citation: Argiles JM, Busquets S, Stemmler B, Lopez-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.
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.