Validation of the Classification for Resectability and Ab... | NCT07569341

Studies
Validation of the Classification for Resectability and Ablatability Criteria for the Treatment of Liver Only Colorectal Metastases

NCT07569341

Sponsor

University Hospital, Linkoeping

Status

Completed

Last Update Posted

May 6, 2026Actual

Enrollment

116Actual

Phase

Not provided

Conditions

Colorectal Adenocarcinoma Metastatic in the Liver

Interventions

Liver resection

Countries

Sweden

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

Apr 2026

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

Nov 1, 2021Actual

Primary Completion Date

Apr 1, 2026Actual

Completion Date

Apr 1, 2026Actual

First Submitted Date

Apr 29, 2026

First Submission Date that Met QC Criteria

Apr 29, 2026

First Posted Date

May 6, 2026Actual

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

Apr 29, 2026

Last Update Posted Date

May 6, 2026Actual

Name	Class
Linkoeping University	OTHER_GOV

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 aim of this study is to validate a proposed classification system regarding overall survival as well as a comparison with patients with liver metastases and extrahepatic metastasis of colorectal cancer. The study also aims to identify the proportion of patients in each group, the proportion of patients converted from 4c to 4b and to compare survival to the patients only treated with chemotherapy.

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

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Name	Type	Description	Arm Group Labels	Other Names
Liver resection	Procedure	Removal or destruction of liver tumors

Measure	Description	Time Frame
Overall survival		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Colorectal liver metastasis.
Discussed at a multidisciplinary tumor board

Exclusion Criteria:

Age less than 18 years.
Previous cancer in the gastrointestinal tract
Ongoing oncological treatment for cancers other than gastrointestinal cancers

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

All patients with colorectal liver metastases assessed at multidisciplinary team conferences in Linköping University Hospital 2021-11-01 -- 2022-12-31

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linköping University Hospital		Linköping			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided