Pancreatic Carcinoma; Lipoprotein a; Overall Survival; PrognosisNCT06316466
Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis
An observational study of Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis, run by jingxue at 1 site in China.
Trial summary
Background: This study aims to assess the prognostic significance of serum lipoprotein (a) [Lp (a)] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis
- What is being tested?
- Lp(a)
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Mar 2024
- 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: This research involved the inclusion of 364 individuals who were diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022, following pathological confirmation. The criteria for inclusion were as follows: (1) Adult patients aged over 18 years; (2) Patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) Complete lipid profiles available within one week prior to diagnosis. Exclusion criteria were as follows: (1) Presence of concurrent malignancies; (2) History of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) Incomplete clinicopathological information.
Who may be able to join
- Adult patients aged over 18 years; (2) Patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) Complete lipid profiles available within one week prior to diagnosis.
Who cannot join
- (1) Presence of concurrent malignancies; (2) History of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) Incomplete clinicopathological information.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Qingdao University
Qingdao, Shandong
Jinyue Liu, 17854269227, liujinyue99@163.com
About this study
Background: This study aims to assess the prognostic significance of serum lipoprotein (a) [Lp (a)] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM).
Methods: A retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022. The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. We applied PSM analysis to minimize selection bias. The study compared OS and PFS between two groups by Kaplan-Meier method and analyzed differences using the log-rank test. Additionally, univariate and multivariate Cox-regression analyses were performed to identify prognostic factors among patients.
- Being tested
- Lp(a)
- Keywords
- Pancreatic carcinoma; Lipoprotein a; Overall survival; Prognosis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lp(a)Other
The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups.
| Study group | Role | What they receive |
|---|---|---|
| the high Lp (a) groups and the low Lp (a) groups | The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. Receives: Other: Lp(a) | |
| the low Lp (a) groups | The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. Receives: Other: Lp(a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
The primary endpoint was overall survival (OS), defined as the time from pathological diagnosis to either death or the most recent follow-up.
Measured: 1-30months
Secondary outcomes (1)
PFS
The secondary measure was the duration from the initial diagnosis to disease progression, referred to as progression-free survival (PFS). Both are measured in months.
Measured: 1-10months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jun 2023
- Primary completion30 Jan 2024
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Carcinoma; Lipoprotein a; Overall Survival; PrognosisStudies 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- jingxue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, jingxue, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316466
- Sponsor's protocol ID
- QYFYWZLL28521
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT06316466
- Acronym / sponsor ID
- QYFYWZLL28521
- Keywords
- Pancreatic carcinoma; Lipoprotein a; Overall survival; Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- jingxueUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Mar 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.
Background: This study aims to assess the prognostic significance of serum lipoprotein (a) [Lp (a)] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM).
Methods: A retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022. The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. We applied PSM analysis to minimize selection bias. The study compared OS and PFS between two groups by Kaplan-Meier method and analyzed differences using the log-rank test. Additionally, univariate and multivariate Cox-regression analyses were performed to identify prognostic factors among patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the high Lp (a) groups and the low Lp (a) groups | – | Other: Lp(a)The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. |
| the low Lp (a) groups | – | Other: Lp(a)The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research involved the inclusion of 364 individuals who were diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022, following pathological confirmation. The criteria for inclusion were as follows: (1) Adult patients aged over 18 years; (2) Patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) Complete lipid profiles available within one week prior to diagnosis. Exclusion criteria were as follows: (1) Presence of concurrent malignancies; (2) History of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) Incomplete clinicopathological information.
Key inclusion criteria (1 listed)
- Adult patients aged over 18 years; (2) Patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) Complete lipid profiles available within one week prior to diagnosis.
Key exclusion criteria (1 listed)
- (1) Presence of concurrent malignancies; (2) History of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) Incomplete clinicopathological information.
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 |
|---|---|---|
| Lp(a)The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. | Other | the high Lp (a) groups and the low Lp (a) groups, the low Lp (a) groups |
Primary outcome
OS
Time frame: 1-30months
The primary endpoint was overall survival (OS), defined as the time from pathological diagnosis to either death or the most recent follow-up.
1 secondary outcome
PFS
Time frame: 1-10months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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.
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 Carcinoma; Lipoprotein a; Overall Survival; Prognosis, run by jingxue at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 18 Mar 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinyue liu (17854269227, liujinyue99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 1-30months). 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 18 Mar 2024.