CachexiaNCT04594863
The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer
An observational study of Cachexia, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cachexia
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are diagnosed with gastrointestinal cancer for the first time without any chemotherapy or radiotherapy
Who may be able to join
- Age between 18 and 90 years old, unlimited gender;
- Patients who are diagnosed with gastrointestinal cancer for the first time and are planning to undergo further treatment;
- Volunteer to participate and sign the informed consent form.
Who cannot join
- Women who are pregnant or lactate;
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730
Kang Yu, MD, +8613801130457, yuk1997@sina.com
Fang Wang, MD, MS, +8615201646084, yours.fang@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Cachexia
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cachexia | patients suffering from cachexia recently | |
| no cachexia | patients are not suffering from cachexia recently |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRT-6 expression
SIRT-6 expression tested by ELISA
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kang Yu, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594863
- Sponsor's protocol ID
- ZS-2525
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25291291Fearon 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.
PubMed 22795476
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT04594863
- Acronym / sponsor ID
- ZS-2525
- Conditions
- Cachexia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cachexia | – | –patients suffering from cachexia recently |
| no cachexia | – | –patients are not suffering from cachexia recently |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with gastrointestinal cancer for the first time without any chemotherapy or radiotherapy
Key inclusion criteria (3 listed)
- Age between 18 and 90 years old, unlimited gender;
- Patients who are diagnosed with gastrointestinal cancer for the first time and are planning to undergo further treatment;
- Volunteer to participate and sign the informed consent form.
Key exclusion criteria (2 listed)
- Women who are pregnant or lactate;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SIRT-6 expression
Time frame: 4 months
SIRT-6 expression tested by ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Background: PubMed 25291291Argiles 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.
- Background: PubMed 22795476Fearon 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.
- Individual participant dataSharing planned: No
Related trials for Cachexia
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
RecruitingPhase 2
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kang Yu study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Yu, MD (+8613801130457, yuk1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRT-6 expression (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.