Ovarian CancerNCT06629831
Systemic Inflammatory Biomarkers in Ovarian Cancer
An observational study of Ovarian Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- group with complications and group without complications
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 27 Sep 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 187 patients who were operated in the gynecologic surgical oncology clinic in one year were retrospectively evaluated.
Who may be able to join
- Patients older than 18 years of age
Who cannot join
- Patients with acute or inflammatory diseases
- Patients with hematological malignancies
- Patients with autoimmune diseases patients who underwent intraoperative hyperchemotherapy (HIPEC)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
BasaksehiCam and Sakura City Hospital
Istanbul, Istanbul
About this study
Official title: The Effect of Preoperative Laboratory Values on Prognostic Factors Following Cytoreductive Surgery for Ovarian Cancer: Neutrophil to Lymphocyte Ratio, Platelet to Lymphocyte Ratio, Lymphocyte to Monocyte Ratio
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.
Read the detailed description
Major gynaecological cancer surgery is a procedure with high complication rates and mortality risk due to both the patient' s old age and comorbidities and the extent of the surgery. Among such surgeries, ovarian cancer-related surgery has the highest mortality rate. Despite advances in early drug therapy and improvements in the cytotoxicity of drugs, ovarian cancer is frequently diagnosed at advanced stages, which further increases morbidity and mortality rates. Although many years have passed, the prognostic role of cytoreductive surgery on survival in ovarian cancers continues to be important. Predicting postoperative outcomes in these surgeries may reduce the length of hospital stay, need for stay in the intensive care unit, complications, and mortality. Therefore, the role of systemic inflammatory biomarkers needs to be comprehensively investigated to understand the carcinogenic mechanisms better.
For this purpose, the investigators planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.
- Conditions
- Ovarian Cancer
- Being tested
- group with complications, group without complications
- Keywords
- systemic inflammatory markers, ovarian cancer, cytoreductive surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group with complicationsOther
Complications in patients undergoing cytoreduction surgery for ovarian cancer
group without complicationsOther
Complications in patients undergoing cytoreduction surgery for ovarian cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cytoreduction surgery for ovarian cancer | Patients undergoing cytoreduction surgery for ovarian cancer Receives: Other: group with complications; Other: group without complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of systemic inflammatory biomarkers
the investigator planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.
Measured: up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629831
- Sponsor's protocol ID
- 2024-59
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25653901Lapchak 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.
PubMed 22301111He 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.
PubMed 23307251Oreskov 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.
PubMed 34477095
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Laboratory Values on Prognostic Factors Following Cytoreductive Surgery for Ovarian Cancer: Neutrophil to Lymphocyte Ratio, Platelet to Lymphocyte Ratio, Lymphocyte to Monocyte Ratio
- ClinicalTrials.gov ID
- NCT06629831
- Acronym / sponsor ID
- 2024-59
- Conditions
- Ovarian Cancer
- Keywords
- systemic inflammatory markers, ovarian cancer, cytoreductive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 8 Oct 2024 (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.
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.
Detailed description
Major gynaecological cancer surgery is a procedure with high complication rates and mortality risk due to both the patient' s old age and comorbidities and the extent of the surgery. Among such surgeries, ovarian cancer-related surgery has the highest mortality rate. Despite advances in early drug therapy and improvements in the cytotoxicity of drugs, ovarian cancer is frequently diagnosed at advanced stages, which further increases morbidity and mortality rates. Although many years have passed, the prognostic role of cytoreductive surgery on survival in ovarian cancers continues to be important. Predicting postoperative outcomes in these surgeries may reduce the length of hospital stay, need for stay in the intensive care unit, complications, and mortality. Therefore, the role of systemic inflammatory biomarkers needs to be comprehensively investigated to understand the carcinogenic mechanisms better.
For this purpose, the investigators planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cytoreduction surgery for ovarian cancer | – | Other: group with complications, Other: group without complicationsPatients undergoing cytoreduction surgery for ovarian cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 187 patients who were operated in the gynecologic surgical oncology clinic in one year were retrospectively evaluated.
Key inclusion criteria (1 listed)
- Patients older than 18 years of age
Key exclusion criteria (3 listed)
- Patients with acute or inflammatory diseases
- Patients with hematological malignancies
- Patients with autoimmune diseases patients who underwent intraoperative hyperchemotherapy (HIPEC)
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 |
|---|---|---|
| group with complicationsComplications in patients undergoing cytoreduction surgery for ovarian cancer | Other | Patients undergoing cytoreduction surgery for ovarian cancer |
| group without complicationsComplications in patients undergoing cytoreduction surgery for ovarian cancer | Other | Patients undergoing cytoreduction surgery for ovarian cancer |
Primary outcome
the rate of systemic inflammatory biomarkers
Time frame: up to 24 hours postoperative
the investigator planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.
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 9 Oct 2024.
- Background: PubMed 25653901Forget 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.
- Background: PubMed 22301111Lapchak 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.
- Results publication: PubMed 23307251He 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.
- Results publication: PubMed 34477095Oreskov 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ovarian Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 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 9 Oct 2024. 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?
the rate of systemic inflammatory biomarkers (time frame: up to 24 hours postoperative). 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 NCT06629831, which also lists 4 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 9 Oct 2024.