Paancreatic CancerNCT05923567
New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase
An observational study of Paancreatic Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Paancreatic Cancer
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Feb 2021to 31 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.
Who may be able to join
- Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.
Who cannot join
- Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels < 9.0 [Lewis antibody-negative patients] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study
Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6
Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.
- Conditions
- Paancreatic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CA19-9<385 & FE-1>100 | Not described | |
| CA19-9<385 and FE-1>100 | Not described | |
| CA19-9>385 & FE-1>100 | Not described | |
| CA19-9>385 & FE-1<100 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3yr overall survival
3-year survival rate for patients who underwent surgery for pancreatic cancer
Measured: Survival period from surgery date, 3 years
Secondary outcomes (1)
1yr disease free survival
Recurrence rate in patients who have undergone surgery for pancreatic cancer within a year
Measured: Period without recurrence from the date of surgery, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start18 Feb 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paancreatic CancerStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Sun Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923567
- Sponsor's protocol ID
- 3-2020-0522
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2023
- Last updated
- 7 Feb 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study
- ClinicalTrials.gov ID
- NCT05923567
- Acronym / sponsor ID
- 3-2020-0522
- Conditions
- Paancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Jun 2023 (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 Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6
Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CA19-9<385 & FE-1>100 | – | – |
| CA19-9<385 and FE-1>100 | – | – |
| CA19-9>385 & FE-1>100 | – | – |
| CA19-9>385 & FE-1<100 | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.
Key inclusion criteria (1 listed)
- Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.
Key exclusion criteria (1 listed)
- Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels < 9.0 [Lewis antibody-negative patients] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).
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
3yr overall survival
Time frame: Survival period from surgery date, 3 years
3-year survival rate for patients who underwent surgery for pancreatic cancer
1 secondary outcome
1yr disease free survival
Time frame: Period without recurrence from the date of surgery, one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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 Paancreatic Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 7 Feb 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 South Korea. 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?
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?
3yr overall survival (time frame: Survival period from surgery date, 3 years). 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 7 Feb 2024.