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

April 10, 2018 updated by: Shuang-xi Li, Peking University

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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);

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jiafu Ji, M.D.,Ph.D.
        • Principal Investigator:
          • Ziyu Li, M.D.,Ph.D.
        • Principal Investigator:
          • Shuangxi Li, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients with advanced gastric cancer or esophagogastric cancer receiving neoadjuvant chemotherapy or chemoradiotherapy will be included for this observational study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
naCT
Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemotherapy.
naCRT
Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological response
Time Frame: One month after surgery
Pathological response
One month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-years overall survival
Time Frame: Three years after surgery
3-years overall survival
Three years after surgery
3-years disease-free survival
Time Frame: Three years after surgery
3-years disease-free survival
Three years after surgery
Postoperative morbidity
Time Frame: One month after surgery
Postoperative morbidity
One month after surgery
yp TNM Stage
Time Frame: One month after surgery
yp TNM Stage
One month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Jiafu Ji, M.D., Ph.D., Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (ACTUAL)

April 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INDEX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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