NCT05959213

Brief 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 .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,034

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
22.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

22.5 years

First QC Date

May 23, 2023

Last Update Submit

July 15, 2023

Conditions

Pancreas Cancer

Keywords

Ca 19.9Pancreatic adenocarcinomaPancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • 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

    20 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 2,034 patients were included in the study.

You may qualify if:

  • All patients undergone pancreatoduodenectomy
  • No preoperative radiological suspicion of lymph node metastases.

You may not qualify if:

  • \- Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 23, 2023

First Posted

July 25, 2023

Study Start

January 1, 2000

Primary Completion

June 30, 2022

Study Completion

March 1, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Upon reasonable request to the Investigator