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

NCT05025371 | Completed

• 1 other identifier: SII-PDAC
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer, Duct Cell Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The last time of follow-up was April 2021

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated in the Surgical Department of Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca between January 2012 and December 2019

You may qualify if:

• Diagnosis of pancreatic ductal adenocarcinoma
• Curative surgical procedure

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Cluj-Napoca, Cluj, 400495, Romania

Location

Related Publications (1)

• Schlanger D, Popa C, Pasca S, Seicean A, Al Hajjar N. The role of systemic immuno-inflammatory factors in resectable pancreatic adenocarcinoma: a cohort retrospective study. World J Surg Oncol. 2022 May 6;20(1):144. doi: 10.1186/s12957-022-02606-1.

  PMID: 35513845 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 27, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-11

Locations

RO (1)