Gastric CancerNCT05075421
Prognostic Values of Inflammation-based Indices in Gastric Cancer
An observational study of Gastric Cancer, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2012to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 years who underwent a surgical procedure for gastric cancer are included in this study
Who may be able to join
- Patients over the age of 18 who underwent a surgical procedure for gastric cancer
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, 06010
About this study
Official title: Comparison of the Prognostic Values of Preoperative Inflammation-based Indices in Patients Undergoing Resection of Gastric Cancer
This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Gastrectomy
- Keywords
- Gastric cancer, Survival, Prognosis, Systemic inflammatory response, Markers
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrectomyProcedure or surgery
Any type of gastrectomy for gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (high marker) | Patients with elevated serum markers Receives: Procedure: Gastrectomy | |
| Group 2 (normal marker) | Patients with normal value of serum markers Receives: Procedure: Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year survival rates
The primary clinical outcome of interest is 5-year survival rates.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Suleyman Utku Celik, Gulhane Training and Research Hospital
- Investigators
- Suleyman U Celik, Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075421
- Sponsor's protocol ID
- Gulhane2021-69
- Status last verified
- Mar 2022
- First submitted
- 2 Oct 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
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.
PubMed 29761518Crumley 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.
PubMed 16479253Crumley 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.
PubMed 16685271Crumley 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.
PubMed 20148314Dutta 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.
PubMed 22444831
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prognostic Values of Preoperative Inflammation-based Indices in Patients Undergoing Resection of Gastric Cancer
- ClinicalTrials.gov ID
- NCT05075421
- Acronym / sponsor ID
- Gulhane2021-69
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Survival, Prognosis, Systemic inflammatory response, Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (high marker) | – | Procedure: GastrectomyPatients with elevated serum markers |
| Group 2 (normal marker) | – | Procedure: GastrectomyPatients with normal value of serum markers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years who underwent a surgical procedure for gastric cancer are included in this study
Key inclusion criteria (1 listed)
- Patients over the age of 18 who underwent a surgical procedure for gastric cancer
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastrectomyAny type of gastrectomy for gastric cancer | Procedure or surgery | Group 1 (high marker), Group 2 (normal marker) |
Primary outcome
5-year survival rates
Time frame: 5 years
The primary clinical outcome of interest is 5-year survival rates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 29761518Wen 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.
- Background: PubMed 16479253Crumley 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.
- Background: PubMed 16685271Crumley 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.
- Background: PubMed 20148314Crumley 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.
- Background: PubMed 22444831Dutta 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suleyman U Celik principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year survival rates (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05075421, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.