Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Me... | NCT02615665

Studies
Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

NCT02615665

Sponsor

University of Milan

Status

Completed

Last Update Posted

Nov 26, 2015Estimated

Enrollment

121Actual

Phase

Not provided

Conditions

Colorectal Liver Metastases

Interventions

Hepatic resection

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

Nov 2015

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 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Nov 18, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 26, 2015Estimated

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

Nov 24, 2015

Last Update Posted Date

Nov 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome.

Detailed Description

The immunoreactivity to CD3+ and NKp46+ cells inside the tumor, at the border between the tumor and the normal liver, and inside the normal liver will be tested by computer-assisted image analyses in patients undergoing liver resection for CLM between 2005 and 2013 preoperatively treated with oxaliplatin or irinotecan with or without bevacizumab or cetuximab. The survival will be assessed in relation to several prognostic factors and to that immunoreactivity.

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

Retention

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatic resection	Procedure	Removal of a part of the liver during surgery		Hepatectomy; liver resection; liver surgery

Measure	Description	Time Frame
Overall survival		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histological proven colorectal liver metastases
complete clinical, surgical, pathological and follow-up data

Exclusion Criteria:

non-radical surgery
incomplete clinical, surgical, pathological and follow-up data

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 with colorectal liver metastases scheduled for surgery at our Unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guido Torzilli, MD, PhD	Humanitas University, Humanitas Research Hospital IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan		Rozzano	Milan	20089	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26330348	Result	Hudspeth K, Donadon M, Cimino M, Pontarini E, Tentorio P, Preti M, Hong M, Bertoletti A, Bicciato S, Invernizzi P, Lugli E, Torzilli G, Gershwin ME, Mavilio D. Human liver-resident CD56(bright)/CD16(neg) NK cells are retained within hepatic sinusoids via the engagement of CCR5 and CXCR6 pathways. J Autoimmun. 2016 Jan;66:40-50. doi: 10.1016/j.jaut.2015.08.011. Epub 2015 Aug 30.
23880068

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative