NCT05075421

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

10 years

First QC Date

October 2, 2021

Last Update Submit

March 16, 2022

Conditions

Gastric Cancer

Keywords

Gastric cancerSurvivalPrognosisSystemic inflammatory responseMarkers

Outcome Measures

Primary Outcomes (1)

  • 5-year survival rates

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

    5 years

Study Arms (2)

Group 1 (high marker)

Patients with elevated serum markers

Procedure: Gastrectomy

Group 2 (normal marker)

Patients with normal value of serum markers

Procedure: Gastrectomy

Interventions

GastrectomyPROCEDURE

Any type of gastrectomy for gastric cancer

Group 1 (high marker)Group 2 (normal marker)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged ≥ 18 years who underwent a surgical procedure for gastric cancer are included in this study

You may qualify if:

  • Patients over the age of 18 who underwent a surgical procedure for gastric cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (5)

  • Wen J, Bedford M, Begum R, Mitchell H, Hodson J, Whiting J, Griffiths E. The value of inflammation based prognostic scores in patients undergoing surgical resection for oesophageal and gastric carcinoma. J Surg Oncol. 2018 Jun;117(8):1697-1707. doi: 10.1002/jso.25057. Epub 2018 May 14.

    PMID: 29761518BACKGROUND

  • Crumley AB, McMillan DC, McKernan M, McDonald AC, Stuart RC. Evaluation of an inflammation-based prognostic score in patients with inoperable gastro-oesophageal cancer. Br J Cancer. 2006 Mar 13;94(5):637-41. doi: 10.1038/sj.bjc.6602998.

    PMID: 16479253BACKGROUND

  • Crumley AB, McMillan DC, McKernan M, Going JJ, Shearer CJ, Stuart RC. An elevated C-reactive protein concentration, prior to surgery, predicts poor cancer-specific survival in patients undergoing resection for gastro-oesophageal cancer. Br J Cancer. 2006 Jun 5;94(11):1568-71. doi: 10.1038/sj.bjc.6603150.

    PMID: 16685271BACKGROUND

  • Crumley AB, Stuart RC, McKernan M, Going JJ, Shearer CJ, McMillan DC. Comparison of pre-treatment clinical prognostic factors in patients with gastro-oesophageal cancer and proposal of a new staging system. J Gastrointest Surg. 2010 May;14(5):781-7. doi: 10.1007/s11605-010-1162-6. Epub 2010 Feb 11.

    PMID: 20148314BACKGROUND

  • Dutta S, Crumley AB, Fullarton GM, Horgan PG, McMillan DC. Comparison of the prognostic value of tumour and patient related factors in patients undergoing potentially curative resection of gastric cancer. Am J Surg. 2012 Sep;204(3):294-9. doi: 10.1016/j.amjsurg.2011.10.015. Epub 2012 Mar 22.

    PMID: 22444831BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Suleyman U Celik

    Gulhane Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 12, 2021

Study Start

January 1, 2012

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD

Locations

TU(1)