Clinical trial NCT02425930: The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer
Official title: The Relationship Between Complement C3 Depletion and Metastatic Gastric Cancer: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Complement Component Deficiency
Surgery
Keywords: gastric cancer
complement system
overal survival
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a confirmed pathological diagnosis of gastric adenocarcinoma would be selected for further observation. Those patients who subsequently underwent a radical tumor resection can be included for final analysis.

Brief summary: This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.

Detailed description: The complement system plays an important role in the development of digestive malignancies. The complement C3 is the point of convergence for the three complement activation pathways. However, the concrete effect of C3 in the development of gastric cancer is still obscured. This study is designed to explore whether complement C3 can be regarded as a predictive factor of postoperative outcomes for postoperative patients with gastric cancer.

This study is designed as a prospective cohort study and included consecutively treated patients. The perioperative plasma value of complement components, such as C3, C4, and CH50, are detected to explore the incidence rate of complement depletion. All enrolled patients are divided into two groups mainly according to the levels of preoperative C3 levels (C3 depletion and Non-C3 depletion groups). The primary endpoints are the 1-year overall survival and disease-free survival, while the secondary endpoints are postoperative complications, length of hospital stay, and hospital charges.

This study would be helpful to confirm the role of complement depletion in anticipated outcomes of postoperative patients with gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of gastric adenocarcinoma
* Radical operation and adjuvant chemotherapy endurable
* Informed consent approved

Exclusion Criteria:

* Age \<18 or \>75 years old
* Pregnancy or lactating woman
* Any primary diagnosis other than gastric cancer
* Confirmed complement deficiency due to immunity dysfunction or other disease
* Required blood transfusion, plasmapheresis, or emergent operation

Primary outcomes:
measure: Overall Survival
timeFrame: one year after surgery
measure: Disease-Free Survival
timeFrame: One year after surgery
Secondary outcomes:
measure: Early complications
timeFrame: within 30 days after a radical operation
measure: Length of hospital stay
timeFrame: an expected average of 4 weeks after admission
measure: Expenditure of hospitalization
timeFrame: an expected average of 4 weeks after admission
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Hospital, Sun Yat-sen University
name: Yulong He, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan K, Ye J, Liu Z, Ren Y, He W, Xu J, He Y, Yuan Y. Complement C3 overexpression activates JAK2/STAT3 pathway and correlates with gastric cancer progression. J Exp Clin Cancer Res. 2020 Jan 13;39(1):9. doi: 10.1186/s13046-019-1514-3.