The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy (Other)
Overall Status
Completed
CT.gov ID
NCT05025371
Collaborator
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor (Other)
312
1
4
77.8

Study Details

Study Description

Brief Summary

Pancreatic cancer is a highly aggressive malignancy, its prognosis remaining poor despite the current advances in treatment. Systemic inflammatory reaction has been recently recognized as an important factor in the progression of cancer. The immune-inflammatory response has been measured through different scores or ratios, that combine the values of circulating immune cells, like neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), prognostic nutritional index (PNI). The utility of these scores in different types of cancer has been more and more discussed. In pancreatic cancer, there has been no definite conclusion regarding the role of systemic immune-inflammatory factors; since controversies still exist, a deeper exploration of this subject, through more studies is welcomed. Our study intends to analyze the utility of systemic immune-inflammatory markers in resectable pancreatic cancer.

Our study is an observational cohort study, with retrospective data collection; it is a single-center study, that takes place in a hospital with experience in hepato-bilio-pancreatic surgery. The investigators intended to evaluate the role of the circulating immune cells (neutrophils, lymphocytes, monocytes) and different immune-inflammatory scores (NLR, LMR, PLR, SII, PNI) in predicting the overall survival of patients diagnosed with pancreatic ductal adenocarcinoma, that undergo curative surgical treatment. The investigators intended to assess the prognosis power of these factors in both preoperative and postoperative settings, as well as their dynamic after surgery. Through this study, the investigators hope to identify easy-to determine and easy-to-use markers that can be incorporated in clinical practice and that can effectively predict survival in pancreatic cancer patients. Nonetheless, the investigators want to explore the dynamic of the immune-inflammatory markers after curative surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: Systemic immune-inflammatory markers

Study Design

Study Type:
Observational
Actual Enrollment :
312 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Overall survival [The last time of follow-up was April 2021]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of pancreatic ductal adenocarcinoma

  • Curative surgical procedure

Exclusion Criteria:
  • Other histopathological types of pancreatic malignancies

  • Palliative surgical interventions

  • Incomplete/ insufficient data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor" Cluj-Napoca Cluj Romania 400495

Sponsors and Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy
  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Diana Schlanger, Dr., Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT05025371
Other Study ID Numbers:
  • SII-PDAC
First Posted:
Aug 27, 2021
Last Update Posted:
Dec 14, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2021