NCT06629831

Brief Summary

In cancer patients, prognostic markers are needed to improve the management and clinical course of both the cancer itself and surgery therefor. Elevated systemic inflammatory markers are associated with morbidity and mortality in most cancer types. In this study, the investigators aimed to determine the prognostic value of inflammatory markers such as neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and lymphocyte to monocyte ratio (LMR) in patients undergoing cytoreductive surgery for ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

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

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 9, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 27, 2024

Last Update Submit

October 5, 2024

Conditions

Keywords

systemic inflammatory markersovarian cancercytoreductive surgery

Outcome Measures

Primary Outcomes (1)

  • the rate of systemic inflammatory biomarkers

    the investigator planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.

    up to 24 hours postoperative

Study Arms (1)

Patients undergoing cytoreduction surgery for ovarian cancer

Patients undergoing cytoreduction surgery for ovarian cancer

Other: group with complicationsOther: group without complications

Interventions

Complications in patients undergoing cytoreduction surgery for ovarian cancer

Patients undergoing cytoreduction surgery for ovarian cancer

Complications in patients undergoing cytoreduction surgery for ovarian cancer

Patients undergoing cytoreduction surgery for ovarian cancer

Eligibility Criteria

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

A total of 187 patients who were operated in the gynecologic surgical oncology clinic in one year were retrospectively evaluated.

You may qualify if:

  • Patients older than 18 years of age

You may not qualify if:

  • Patients with acute or inflammatory diseases
  • Patients with hematological malignancies
  • Patients with autoimmune diseases patients who underwent intraoperative hyperchemotherapy (HIPEC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BasaksehiCam and Sakura City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • He W, Yin C, Guo G, Jiang C, Wang F, Qiu H, Chen X, Rong R, Zhang B, Xia L. Initial neutrophil lymphocyte ratio is superior to platelet lymphocyte ratio as an adverse prognostic and predictive factor in metastatic colorectal cancer. Med Oncol. 2013 Mar;30(1):439. doi: 10.1007/s12032-012-0439-x. Epub 2013 Jan 10.

    PMID: 23307251BACKGROUND
  • Oreskov KO, Jensen KK, Gogenur I, Godthaab C, Jorgensen AB, Oreskov JO, Burcharth J, Ekeloef S. Limited value of preoperative neutrophil-to-lymphocyte ratio to predict post-operative outcomes after major emergency abdominal surgery. Dan Med J. 2021 Aug 20;68(9):A09200689.

    PMID: 34477095BACKGROUND
  • Forget P, Dinant V, De Kock M. Is the Neutrophil-to-Lymphocyte Ratio more correlated than C-reactive protein with postoperative complications after major abdominal surgery? PeerJ. 2015 Jan 13;3:e713. doi: 10.7717/peerj.713. eCollection 2015.

    PMID: 25653901BACKGROUND
  • Lapchak PH, Kannan L, Ioannou A, Rani P, Karian P, Dalle Lucca JJ, Tsokos GC. Platelets orchestrate remote tissue damage after mesenteric ischemia-reperfusion. Am J Physiol Gastrointest Liver Physiol. 2012 Apr 15;302(8):G888-97. doi: 10.1152/ajpgi.00499.2011. Epub 2012 Feb 2.

    PMID: 22301111BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 8, 2024

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

September 27, 2024

Last Updated

October 9, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations