Analgesia aNd caNcer recUrrence Lung cAncer Resection | NCT04656769

Studies
Analgesia aNd caNcer recUrrence Lung cAncer Resection

NCT04656769

Sponsor

University of Turin, Italy

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

382Actual

Phase

Not provided

Conditions

Recurrence Tumor
Opioid Use, Unspecified
Analgesia
Thoracic Surgery

Interventions

Peridural analgesia

Countries

Italy

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

Dec 2020

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

Dec 17, 2018Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Nov 30, 2020

First Submission Date that Met QC Criteria

Nov 30, 2020

First Posted Date

Dec 7, 2020Actual

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

Dec 18, 2020

Last Update Posted Date

Dec 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.

Detailed Description

Not provided

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

382Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PERI group			Procedure: Peridural analgesia
EV group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peridural analgesia	Procedure	We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.	PERI group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cumulative incidence of recurrence and the overall survival		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 yrs
Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Exclusion Criteria:

Age<18aa
Pregnancy
Day hospital patients

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

Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luca Brazzi, Professor	University of Torino	Study Chair
Giulio L Rosboch, MD	A.O.U. Città della Salute e della Scienza	Principal Investigator
Ilaria De Domenici, MD	University of Torino	Study Director
Edoardo Ceraolo, MD	A.O.U. Città della Salute e della Scienza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Città della Salute e della Scienza di Torino		Torino		10100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence
D000377	Agnosia

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

Browse Leaves

Not provided

Browse Branches

Not provided