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OpenTrials
Completed

NCT Number: NCT05025371

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"

Cluj-Napoca, Cluj, 400495, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of pancreatic ductal adenocarcinoma
  • Curative surgical procedure

Exclusion criteria

  • Other histopathological types of pancreatic malignancies
  • Palliative surgical interventions
  • Incomplete/ insufficient data

Treatment and study plan

Systemic immune-inflammatory markers

Other

Systemic immune-inflammatory markers used in this study: total neutrophil count, total lymphocyte count, total monocyte count, total platelet count, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), prognostic nutritional index (PNI)

Primary outcomes

  1. Overall survival

    Time frame: The last time of follow-up was April 2021

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Collaborators

  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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