Pancreas CancerICALYRANCT05959213
Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.
An observational study of Pancreas Cancer, run by Fondazione Policlinico Universitario Campus Bio-Medico.
Trial summary
In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- How many people
- 2,034 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 Mar 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: A total of 2,034 patients were included in the study.
Who may be able to join
- All patients undergone pancreatoduodenectomy
- No preoperative radiological suspicion of lymph node metastases.
Who cannot join
- Age < 18
About this study
Official title: Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas: a Further Plea for Biological Resectability Criteria.
In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .
Read the detailed description
A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.
- Conditions
- Pancreas Cancer
- Keywords
- Ca 19.9, Pancreatic adenocarcinoma, Pancreatoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative data - Preoperatory levels of CA 19.9 (U/ml)
Define relation of quantitative data (CA 19.9 (U/ml)) with nodal positivity at the final pathological report
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Jan 2000
- Primary completion30 Jun 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas 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
- 2,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Farolfi, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959213
- Sponsor's protocol ID
- FPUCampusBioMedico
- Acronym
- ICALYRA
- Status last verified
- Jul 2023
- First submitted
- 23 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request to the Investigator
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas: a Further Plea for Biological Resectability Criteria.
- ClinicalTrials.gov ID
- NCT05959213
- Acronym / sponsor ID
- ICALYRA / FPUCampusBioMedico
- Conditions
- Pancreas Cancer
- Keywords
- Ca 19.9, Pancreatic adenocarcinoma, Pancreatoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,034 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Jul 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.
In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .
Detailed description
A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.
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
- A total of 2,034 patients were included in the study.
Key inclusion criteria (2 listed)
- All patients undergone pancreatoduodenectomy
- No preoperative radiological suspicion of lymph node metastases.
Key exclusion criteria (1 listed)
- Age < 18
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
Quantitative data - Preoperatory levels of CA 19.9 (U/ml)
Time frame: 20 years
Define relation of quantitative data (CA 19.9 (U/ml)) with nodal positivity at the final pathological report
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 25 Jul 2023.
- Individual participant dataSharing planned: No. Upon reasonable request to the Investigator
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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 Pancreas Cancer, run by Fondazione Policlinico Universitario Campus Bio-Medico.
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 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 25 Jul 2023. 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?
Quantitative data - Preoperatory levels of CA 19.9 (U/ml) (time frame: 20 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 25 Jul 2023.