Pancreatic CancerSIINCT05012540
SII And PALBI is Associated With the Prognosis of Pancreatic Cancer Surgery(SII,PALBI)
An observational study of Pancreatic Cancer, run by The Affiliated Hospital of Qingdao University.
Trial summary
Chronic inflammation and immune dysfunction play a key role in the development of tumors. The aim of the study is to investigate the predictive value of SII and PALBI grade for the patients with pancreatic cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Dec 2020
- 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: age≥18 years old
Who may be able to join
- Age ≥ 18 years old; It was diagnosed as pancreatic cancer by clinical manifestations, laboratory examination indexes, and pathology, and then surgically removed; Agree to participate in this study and sign an informed consent form;
Who cannot join
- All kinds of acute or chronic inflammation, infectious diseases and blood system diseases; Metastasis of tumors in other parts; Benign pancreatic diseases such as chronic pancreatitis and autoimmune pancreatitis; Periampullary tumors without pancreatic cancer; Suspicious pancreatic cancer patients who cannot be diagnosed; Refuse to follow up.
About this study
Official title: Systemic Immune-inflammation Index (SII) And Platelet-albumin-bilirubin (PALBI) is Associated With the Prognosis of Pancreatic Cancer Surgery
Chronic inflammation and immune dysfunction play a key role in the development of tumors. The aim of the study is to investigate the predictive value of SII and PALBI grade for the patients with pancreatic cancer surgery.
Read the detailed description
The systemic immune-inflammation index(SII), based on the counts of platelets, neutrophils, and lymphocytes,was first found to be related to the prognosis of patients in melanoma12, and was subsequently confirmed in malignant tumors such as hepatocellular carcinoma13,and lung cancer12. A retrospective multicenter cohort study showed that bilirubin levels can interfere some inflammation index'prognosis of PDAC7.The platelet-albumin-bilirubin (platelet-albumin-bilirubin, PALBI) grade as a prognostic indicator of inflammation has been found in recent years, and its role has been confirmed in patients with liver cirrhosis14,15 and hepatocellular carcinoma 16, but there is no research to verify its role in patients with pancreatic cancer. This study aims to verify the predictive value of systemic immune inflammation index (SII) and platelet-albumin-bilirubin grade (PALBI) for the prognosis of patients with pancreatic cancer surgery, and to explore the significance of other inflammatory indicators in the overall survival(OS) and disease-free survival (DFS).
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, Systemic immune inflammation index, Platelet-albumin-bilirubin grade
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall survival
The overall survival（OS）was defined as time between primary surgery and the patients' death. Death from other cause than PDAC or survival until the end of the observation period was considered as censored observations
Measured: 2013.8-2019.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Aug 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012540
- Sponsor's protocol ID
- QYFYWZLL26364
- Acronym
- SII
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Immune-inflammation Index (SII) And Platelet-albumin-bilirubin (PALBI) is Associated With the Prognosis of Pancreatic Cancer Surgery
- ClinicalTrials.gov ID
- NCT05012540
- Acronym / sponsor ID
- SII / QYFYWZLL26364
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, Systemic immune inflammation index, Platelet-albumin-bilirubin grade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 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.
Chronic inflammation and immune dysfunction play a key role in the development of tumors. The aim of the study is to investigate the predictive value of SII and PALBI grade for the patients with pancreatic cancer surgery.
Detailed description
The systemic immune-inflammation index(SII), based on the counts of platelets, neutrophils, and lymphocytes,was first found to be related to the prognosis of patients in melanoma12, and was subsequently confirmed in malignant tumors such as hepatocellular carcinoma13,and lung cancer12. A retrospective multicenter cohort study showed that bilirubin levels can interfere some inflammation index'prognosis of PDAC7.The platelet-albumin-bilirubin (platelet-albumin-bilirubin, PALBI) grade as a prognostic indicator of inflammation has been found in recent years, and its role has been confirmed in patients with liver cirrhosis14,15 and hepatocellular carcinoma 16, but there is no research to verify its role in patients with pancreatic cancer. This study aims to verify the predictive value of systemic immune inflammation index (SII) and platelet-albumin-bilirubin grade (PALBI) for the prognosis of patients with pancreatic cancer surgery, and to explore the significance of other inflammatory indicators in the overall survival(OS) and disease-free survival (DFS).
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
- age≥18 years old
Key inclusion criteria (1 listed)
- Age ≥ 18 years old; It was diagnosed as pancreatic cancer by clinical manifestations, laboratory examination indexes, and pathology, and then surgically removed; Agree to participate in this study and sign an informed consent form;
Key exclusion criteria (1 listed)
- All kinds of acute or chronic inflammation, infectious diseases and blood system diseases; Metastasis of tumors in other parts; Benign pancreatic diseases such as chronic pancreatitis and autoimmune pancreatitis; Periampullary tumors without pancreatic cancer; Suspicious pancreatic cancer patients who cannot be diagnosed; Refuse to follow up.
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
The overall survival
Time frame: 2013.8-2019.12
The overall survival（OS）was defined as time between primary surgery and the patients' death. Death from other cause than PDAC or survival until the end of the observation period was considered as censored observations
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 19 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by The Affiliated Hospital of Qingdao University.
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 1 inclusion and 1 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 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The overall survival (time frame: 2013.8-2019.12). 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 19 Aug 2021.