NCT02615665

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

2.6 years

First QC Date

November 18, 2015

Last Update Submit

November 24, 2015

Conditions

Keywords

NK-cellsT-cells

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    5 years

Interventions

Removal of a part of the liver during surgery

Also known as: Hepatectomy; liver resection; liver surgery

Eligibility Criteria

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

Patients with colorectal liver metastases scheduled for surgery at our Unit.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Rozzano, Milan, 20089, Italy

Location

Related Publications (2)

  • 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.

  • Hudspeth K, Pontarini E, Tentorio P, Cimino M, Donadon M, Torzilli G, Lugli E, Della Bella S, Gershwin ME, Mavilio D. The role of natural killer cells in autoimmune liver disease: a comprehensive review. J Autoimmun. 2013 Oct;46:55-65. doi: 10.1016/j.jaut.2013.07.003. Epub 2013 Jul 21.

Biospecimen

Retention: SAMPLES WITHOUT DNA

We use the surgical specimens.

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Guido Torzilli, MD, PhD

    Humanitas University, Humanitas Research Hospital IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 26, 2015

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations