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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03493880
Other study ID # INdex
Secondary ID
Status Recruiting
Phase
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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