Prognostic Values of Inflammation-based Indices in Gastric Cancer

Sponsor
Gulhane Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05075421
Collaborator
(none)
350
1
120
2.9

Study Details

Study Description

Brief Summary

This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gastrectomy

Detailed Description

Gastric cancer is one of the most common and deadly cancers worldwide. Based on GLOBOCAN 2018 data, it is the fifth most common malignancy and the third leading cause of cancer deaths, with an estimated 783,000 deaths in 2018. Despite advances in diagnosis and management strategies, outcomes for patients diagnosed with gastric cancer still remain poor and the five-year survival is approximately %20. In addition, there is marked heterogeneity in the duration of survival among patients. Hence, there are increasing research efforts towards the identification of possible predictive clinical, pathological, or biologic factors to determine more accurate patient stratification, which will improve clinical decision-making and possibly contribute to more rational study design and analysis. Systemic inflammation is known to play a crucial role in the pathogenesis, development, and progression of cancer. Preoperative inflammation-based indices, such as the Glasgow prognostic score (GPS), modified Glasgow prognostic score (mGPS), neutrophil-lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), prognostic index (PI), prognostic nutritional index (PNI), CRP/albumin ratio, systemic inflammation score (SIS), modified systemic inflammation score (mSIS), have been found to have potential prognostic values in various cancer. Previous studies have suggested that several of these scoring systems may have a role in predicting survival in patients with upper gastrointestinal cancer. These scores are all derived from blood tests that are already routinely performed in clinical practice and thus have the potential to offer valuable additional information that may help to guide patient management. This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.

Study Design

Study Type:
Observational
Actual Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of the Prognostic Values of Preoperative Inflammation-based Indices in Patients Undergoing Resection of Gastric Cancer
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Group 1 (high marker)

Patients with elevated serum markers

Procedure: Gastrectomy
Any type of gastrectomy for gastric cancer

Group 2 (normal marker)

Patients with normal value of serum markers

Procedure: Gastrectomy
Any type of gastrectomy for gastric cancer

Outcome Measures

Primary Outcome Measures

  1. 5-year survival rates [5 years]

    The primary clinical outcome of interest is 5-year survival rates.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients over the age of 18 who underwent a surgical procedure for gastric cancer
Exclusion Criteria:
  • Patients < 18 years of age

  • Patients with no routine blood examination before surgery or incomplete medical records

  • Patients followed up less than 3 months

  • Patients with additional malignancy

  • Patients having tumors that invading adjacent organs

  • Patients with adjacent or distant metastasis

  • Patients receiving neoadjuvant therapy (chemo- or radiotherapy)

  • Patients with previous malignancy history

  • Patients with a clinical evidence of infection

  • Patients with a history of preoperative use of anti-inflammatory drugs or immunosuppressive treatment

  • Patients with a history of chronic inflammatory disease or autoimmune disease

  • Patients who underwent emergency surgical resection

  • Patients who have undergone R1/R2 resection or those with positive peripheral margins

  • Patients with missing data on follow-up

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gulhane Training and Research Hospital Ankara Turkey 06010

Sponsors and Collaborators

  • Gulhane Training and Research Hospital

Investigators

  • Principal Investigator: Suleyman U Celik, Gulhane Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Suleyman Utku Celik, Principal Investigator, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05075421
Other Study ID Numbers:
  • Gulhane2021-69
First Posted:
Oct 12, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suleyman Utku Celik, Principal Investigator, Gulhane Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022