Pancreatic Cancer, AdultNCT06747481
Neutrophil-to-lymphocyte Ratio and CA 19.9 as Predictors of Perineural Invasion in Pancreatic Cancer
An observational study of Pancreatic Cancer, Adult and Perineural Invasion, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer, Adult, Perineural Invasion, Neutrophil-to-Lymphocyte Ratio
- How many people
- 323 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with pancreatic cancer and operated on between January 2020 and December 2024 from the participating centers who meet all the inclusion criteria and none of the exclusion criteria will be included.
Who may be able to join
- Patient with a histopathological diagnosis of adenocarcinoma.
- Surgical resection of the neoplasm.
- Preoperative blood count allowing calculation of the neutrophil-to-lymphocyte ratio and preoperative CA 19.9, both before and after neoadjuvant therapy.
Who cannot join
- Patients with a diagnosis of another histological type.
- Patients with incomplete data.
- Patients who were not operated on.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University Hospital of Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Pau Plá Sánchez, 34 620541910, paups88@gmail.com
Pau Plá Sánchez
About this study
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.
Read more
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.
- Keywords
- pancreatic cancer, perineural invasion, Neutrophil-to-Lymphocyte Ratio, CA 19.9
- Medical subject headings
- Pancreatic cancer, adult, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineural invasion
The correlation between the preoperative neutrophil-to-lymphocyte ratio (NLR) and CA 19.9 with the presence of histopathologically confirmed perineural invasion in patients with pancreatic cancer
Measured: Within 30 days prior to surgery (for NLR and CA 19.9) and immediately following surgery for histopathological confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pau Plá Sánchez, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747481
- Sponsor's protocol ID
- 2024-260-1
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-to-lymphocyte Ratio and CA 19.9 as Predictors of Perineural Invasion in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06747481
- Acronym / sponsor ID
- 2024-260-1
- Keywords
- pancreatic cancer, perineural invasion, Neutrophil-to-Lymphocyte Ratio, CA 19.9
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with pancreatic cancer and operated on between January 2020 and December 2024 from the participating centers who meet all the inclusion criteria and none of the exclusion criteria will be included.
Key inclusion criteria (3 listed)
- Patient with a histopathological diagnosis of adenocarcinoma.
- Surgical resection of the neoplasm.
- Preoperative blood count allowing calculation of the neutrophil-to-lymphocyte ratio and preoperative CA 19.9, both before and after neoadjuvant therapy.
Key exclusion criteria (3 listed)
- Patients with a diagnosis of another histological type.
- Patients with incomplete data.
- Patients who were not operated on.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perineural invasion
Time frame: Within 30 days prior to surgery (for NLR and CA 19.9) and immediately following surgery for histopathological confirmation
The correlation between the preoperative neutrophil-to-lymphocyte ratio (NLR) and CA 19.9 with the presence of histopathologically confirmed perineural invasion in patients with pancreatic cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, Adult and Perineural Invasion, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pau Plá Sánchez (34 620541910, paups88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineural invasion (time frame: Within 30 days prior to surgery (for NLR and CA 19.9) and immediately following surgery for histopathological confirmation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.