Preoperative CA 19.9 Level Predicts Lymph Node Metastasis... | NCT05959213

Studies
Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.

NCT05959213

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Status

Completed

Last Update Posted

Jul 25, 2023Actual

Enrollment

2,034Actual

Phase

Not provided

Conditions

Pancreas Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2000Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

May 23, 2023

First Submission Date that Met QC Criteria

Jul 15, 2023

First Posted Date

Jul 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2023

Last Update Posted Date

Jul 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tommaso Farolfi, Principal investigator, Fondazione Policlinico Universitario Campus Bio-MedicoPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Campus Bio-MedicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,034Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Age < 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Upon reasonable request to the Investigator

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided