The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments

Gastric Cancer Clinical Trial

Official title:

The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments: Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03493880
• Other study ID #: INdex
• Status: Recruiting
• First received: March 22, 2018
• Last updated: April 10, 2018
• Start date: September 1, 2015
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2018
• Source: Peking University
• Contact: Shuangxi Li, M.D., Ph.D.
• Email: lishx[@]hsc.pku.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.

Description:

The immune (systemic inflammation) index includes:

NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index);

The nutrition index includes:

NRS2002; PNI (Prognostic Nutrition Index);

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma

• Received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy

• Diagnosed clinical advanced gastric cancer or esophagogastric cancer

Exclusion Criteria:

• Lack of immuno-nutrition data

Related Conditions & MeSH terms

• Gastric Cancer
• Neoadjuvant Chemoradiotherapy
• Neoadjuvant Chemotherapy
• Nutrition Aspect of Cancer
• Stomach Neoplasms
• Systemic Inflammatory Response Syndrome
• Systemic Inflammatory Response Syndrome (SIRS)

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological response	Pathological response	One month after surgery
Secondary	3-years overall survival	3-years overall survival	Three years after surgery
Secondary	3-years disease-free survival	3-years disease-free survival	Three years after surgery
Secondary	Postoperative morbidity	Postoperative morbidity	One month after surgery
Secondary	yp TNM Stage	yp TNM Stage	One month after surgery