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NCT06747481

Neutrophil-to-lymphocyte Ratio and CA 19.9 as Predictors of Perineural Invasion in Pancreatic Cancer

Recruiting now Last updated 24 December 2024
What this trial tests

trial in Pancreatic Cancer, Adult in 323 participants. Currently enrolling.

Timeline
1 January 2020
Primary endpoint
31 December 2024
30 September 2025

Quick facts

Lead sponsorUniversity of Las Palmas de Gran Canaria
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment323
Start date1 January 2020
Primary completion31 December 2024
Estimated completion30 September 2025
Sites1 location across Spain

Conditions studied

Sponsor

University of Las Palmas de Gran Canaria

Who can join

Eligibility, any sex, with Pancreatic Cancer, Adult or Perineural Invasion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pancreatic cancer has an incidence of 1,401,450 new cases diagnosed annually worldwide and is the third leading cause of cancer-related death in Spain. This disease is associated with a poor prognosis, reflected by a 5-year survival rate of less than 5% when all stages are grouped together. Several prognostic factors for pancreatic cancer have been identified. The most relevant include preoperative levels of carbohydrate antigen 19-9 (CA 19.9), surgical margins after resection, venous and/or arterial vascular involvement, and histopathological features such as affected locoregional lymph nodes, or perineural and lymphovascular invasion. Among all these factors, perineural invasion may be the primary independent factor affecting prognosis, particularly in patients with relatively favorable pathological features. The identification of perineural invasion before surgery could influence the clinical management of these patients. It may facilitate risk stratification, allowing the identification of patients who would benefit most from neoadjuvant treatments or more aggressive surgical procedures, such as vascular resections. However, perineural involvement is very difficult to detect preoperatively. Only a few studies have analyzed the possible relationship between CA 19.9 and perineural invasion, and their results are inconsistent. Alternatively, some studies have demonstrated the utility of preoperative multidetector computed tomography in detecting extrapancreatic perineural invasion. However, these radiological tests are still not useful for directly detecting microscopic perineural invasion, especially in early stages. On the other hand, in recent years, evidence has supported that the systemic inflammatory response may play an important role in the prognosis of different malignancies. Among these inflammatory markers, the neutrophil-to-lymphocyte ratio (NLR) has gained prominence. Regarding pancreatic cancer, many studies suggest that elevated preoperative NLR levels are associated with a worse prognosis. However, no studies have yet been published analyzing a possible relationship between this inflammatory marker and perineural invasion. The main objective of this study is to correlate the neutrophil-to-lymphocyte ratio (NLR) and CA 19.9 with histopathologically confirmed perineural invasion and, in this way, investigate these data as potential preoperative markers of perineural invasion in pancreatic cancer. Our working hypothesis is that preoperative NLR and CA 19.9 are potential markers of perineural invasion. As secondary objectives, we aim to study the effect of neoadjuvant therapy on inflammatory markers (NLR) and tumor markers (CEA and CA 19.9) in pancreatic cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Perineural Invasion in Pancreatic Ductal Adenocarcinoma: Recapitulating Its Importance and Defining Future Directions.
    Lovecek M, Dirimtekin E, Garajová I, Gasparini G, et al · · 2025 · cited 2× · PMID 40981722 · DOI 10.1002/ueg2.70118

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Other recruiting trials for Pancreatic Cancer, Adult

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