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

NCT ID: NCT05025371

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreas Cancer, Duct Cell Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Systemic immune-inflammatory markers

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of pancreatic ductal adenocarcinoma
* Curative surgical procedure

Exclusion Criteria

* Other histopathological types of pancreatic malignancies
* Palliative surgical interventions
* Incomplete/ insufficient data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Diana Schlanger

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

References

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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.

Reference Type DERIVED
PMID: 35513845 (View on PubMed)

Other Identifiers

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SII-PDAC

Identifier Type: -

Identifier Source: org_study_id