NCT04594863

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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 14, 2020

Last Update Submit

October 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • SIRT-6 expression

    SIRT-6 expression tested by ELISA

    4 months

Study Arms (2)

cachexia

patients suffering from cachexia recently

no cachexia

patients are not suffering from cachexia recently

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are diagnosed with gastrointestinal cancer for the first time without any chemotherapy or radiotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospita

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

  • 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.

    PMID: 25291291BACKGROUND
  • 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.

    PMID: 22795476BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood sample

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kang Yu

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

November 1, 2020

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations