Pancreas Cancer, Duct Cell AdenocarcinomaNCT05025371
The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma
An observational study of Pancreas Cancer, Duct Cell Adenocarcinoma, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Duct Cell Adenocarcinoma
- What is being tested?
- Systemic immune-inflammatory markers
- How many people
- 312 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Diagnosis of pancreatic ductal adenocarcinoma
- Curative surgical procedure
Who cannot join
- Other histopathological types of pancreatic malignancies
- Palliative surgical interventions
- Incomplete/ insufficient data
Trial locations and contacts
1 site in 1 country.
Romania1 site
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
Cluj-Napoca, Cluj, 400495
About this study
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.
- Being tested
- Systemic immune-inflammatory markers
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic immune-inflammatory markersOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: The last time of follow-up was April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Apr 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas Cancer, Duct Cell AdenocarcinomaStudies 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
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Responsible party
- Principal investigator, Diana Schlanger, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025371
- Sponsor's protocol ID
- SII-PDAC
- Status last verified
- Nov 2021
- First submitted
- 26 Aug 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35513845
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05025371
- Acronym / sponsor ID
- SII-PDAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 27 Aug 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Diagnosis of pancreatic ductal adenocarcinoma
- Curative surgical procedure
Key exclusion criteria (3 listed)
- Other histopathological types of pancreatic malignancies
- Palliative surgical interventions
- Incomplete/ insufficient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic immune-inflammatory markersSystemic 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) | Other | – |
Primary outcome
Overall survival
Time frame: The last time of follow-up was April 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Derived from this study: PubMed 35513845Schlanger 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreas Cancer, Duct Cell Adenocarcinoma, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 2 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: finished, as of the sponsor's last update on 14 Dec 2021. 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: The last time of follow-up was April 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05025371, which also lists 1 linked publication.
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 14 Dec 2021.