- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05075421
Prognostic Values of Inflammation-based Indices in Gastric Cancer
16. marts 2022 opdateret af: Suleyman Utku Celik, Gulhane Training and Research Hospital
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
350
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ankara, Kalkun, 06010
- Gulhane Training and Research Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients aged ≥ 18 years who underwent a surgical procedure for gastric cancer are included in this study
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Group 1 (high marker)
Patients with elevated serum markers
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Any type of gastrectomy for gastric cancer
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Group 2 (normal marker)
Patients with normal value of serum markers
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Any type of gastrectomy for gastric cancer
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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5-year survival rates
Tidsramme: 5 years
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The primary clinical outcome of interest is 5-year survival rates.
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5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Suleyman U Celik, Gulhane Training and Research Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2012
Primær færdiggørelse (Faktiske)
31. december 2021
Studieafslutning (Faktiske)
31. december 2021
Datoer for studieregistrering
Først indsendt
2. oktober 2021
Først indsendt, der opfyldte QC-kriterier
2. oktober 2021
Først opslået (Faktiske)
12. oktober 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Gulhane2021-69
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There is no plan to share IPD
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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