Pancreatic NeoplasmsNCT06553040
The Effect of Albumin Value, HALP Score, and LCR Value on Predicting Survival and Recurrence in Patients With Pancreatic Adenocarcinoma
An observational study of Pancreatic Neoplasms and Pancreas Cancer, run by Ege University.
Trial summary
The aim of this study is to investigate whether the albumin value and the ratios of biochemical markers; hemoglobin, albumin, lymphocyte and platelet (HALP score) and lymphocyte-C-reactive protein ratio (LCR) can predict the survival and recurrence of the disease in patients with pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreas Cancer
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2023
- 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: The study included 87 patients who underwent either pancreaticoduodenectomy (Whipple or total pancreatectomy) operations for pancreatic adenocarcinoma in the General Surgery Clinic of Ege University Hospital between January 2017 and December 2021.
Who may be able to join
- Whipple operation and total pancreatectomy due to pathologically confirmed pancreatic adenocarcinoma
Who cannot join
- Patients with other malignant tumors (choledochal tumor, papilla tumor and duodenal tumor)
About this study
The aim of this study is to investigate whether the albumin value and the ratios of biochemical markers; hemoglobin, albumin, lymphocyte and platelet (HALP score) and lymphocyte-C-reactive protein ratio (LCR) can predict the survival and recurrence of the disease in patients with pancreatic adenocarcinoma.
- Conditions
- Pancreatic Neoplasms, Pancreas Cancer
- Keywords
- Pancreatic adenocancer, albumin, hemoglobin, lymphocyte, platelet
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival Times
Measured: 4 Years
HALP Score
Hemoglobin x Albumin x Lymphocyte / Platelet
Measured: 4 Years
Overall Survival Time
Measured: 4 Years
LCR Score
Lymphocyte / CRP
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jan 2017
- Primary completion1 Dec 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ege 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tufan Gumus, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553040
- Sponsor's protocol ID
- EUTFHALPSCOREFORPANCREAS
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Albumin Value, HALP Score, and LCR Value on Predicting Survival and Recurrence in Patients With Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06553040
- Acronym / sponsor ID
- EUTFHALPSCOREFORPANCREAS
- Conditions
- Pancreatic Neoplasms, Pancreas Cancer
- Keywords
- Pancreatic adenocancer, albumin, hemoglobin, lymphocyte, platelet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 14 Aug 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.
The aim of this study is to investigate whether the albumin value and the ratios of biochemical markers; hemoglobin, albumin, lymphocyte and platelet (HALP score) and lymphocyte-C-reactive protein ratio (LCR) can predict the survival and recurrence of the disease in patients with pancreatic adenocarcinoma.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 87 patients who underwent either pancreaticoduodenectomy (Whipple or total pancreatectomy) operations for pancreatic adenocarcinoma in the General Surgery Clinic of Ege University Hospital between January 2017 and December 2021.
Key inclusion criteria (1 listed)
- Whipple operation and total pancreatectomy due to pathologically confirmed pancreatic adenocarcinoma
Key exclusion criteria (1 listed)
- Patients with other malignant tumors (choledochal tumor, papilla tumor and duodenal tumor)
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
Disease-Free Survival Times
Time frame: 4 Years
HALP Score
Time frame: 4 Years
Hemoglobin x Albumin x Lymphocyte / Platelet
Overall Survival Time
Time frame: 4 Years
LCR Score
Time frame: 4 Years
Lymphocyte / CRP
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 Aug 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. 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 Neoplasms and Pancreas Cancer, run by Ege 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 14 Aug 2024. 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?
Disease-Free Survival Times (time frame: 4 Years). The study lists 4 primary outcomes in all. 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 14 Aug 2024.