Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time

April 9, 2026 updated by: Memorial Sloan Kettering Cancer Center
This study is being done to learn more about health related quality of life factors in people having surgery for colorectal liver metastasis. The investigators will look at how these factors may change over time. The information gained from this study will help the investigators to understand the long-term effects that cancer treatments have on the health related quality of life of patients. This information is of high value and will help doctors talk to patients about the possible effects of their operations. While many patients live a long time after such operations, the studies that have been done do not tell the full story of what patients go through after surgery. This study will help us to understand cancer treatment from the patient's perspective. It will also help cancer patients make better decisions about their treatment options and will help them know what to expect after the operation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent and Follow up)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent and Follow up)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack (Consent and Follow up)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Consent and Follow Up)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent and follow up)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled to undergo liver resection who meet the established criteria will be approached for participation in this study during their preoperative visit. Should patients not undergo their liver resection surgery within 30 days of consent they will be excluded and replaced. Patients undergoing a two stage resection will have their time point frozen for up to six months after their initial surgery. If the time before the second stage of their resection exceeds six months, these patients will be excluded and replaced. The time point will restart at the completion of the second time point. If the patient has an incomplete resection without mention of a second stage resection, the patient will be made ineligible, taken off study, and replaced.

Description

Inclusion Criteria:

  • Diagnosis of Colorectal cancer liver metastases (CRLM)
  • > 18 years of age
  • Absence of unresectable extrahepatic disease
  • No previous liver surgery for CRLM
  • Clinical risk score (CRS) >/= 3 or > 4 tumors
  • CRS includes the following variables;
  • Lymph node positive primary
  • Disease free interval <12 months
  • CEA level >200ng/mL (highest CEA level within 6 months prior to surgery, not including day of surgery)
  • Tumor size > 5cm
  • Number of tumors >1(based on most recent scan or pathology before liver resection)
  • Each variable is given a score of one and summed to give final CRS
  • Clinical risk score (CRS) < 3 with pending variables that cannot be determined preoperatively
  • If CRS is still < 3 postoperatively, these patients will be excluded and replaced (inevaluable).
  • Ability to read and write in English
  • Undergoing liver resection/ ablation for CRLM
  • Underwent liver resection/ ablation for CRLM, but not their primary tumors

Exclusion Criteria:

  • Non-English speaking
  • Inability to read and/or write
  • International Patients
  • Concurrent malignancy (excluding non-melanoma skin cancers)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients following hepatectomy
Behavioral: HRQoL questionnaires.

Questionnaires/Forms to be completed preoperatively in clinic with assistance from research study administrator:

  • Baseline sociodemographic and clinical variable data sheet (RSA)
  • EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
  • Baseline disease status and treatment assessment questionnaire Questionnaires/Forms to be completed at first postoperative clinic visit:
  • EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS

Questionnaires/Forms to be mailed to patients at ± 2 month window at the following time points 6,12,18,24, and 36 months following hepatectomy:

  • EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
  • Post surgical follow up disease status and treatment assessment questionnaire
  • At 8 weeks following the mailing of the initial questionnaire package if no response has been received, research personnel will attempt to contact participants by phone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
changes in the quality of life (QoL)
Time Frame: 3 years
in patients at high risk of recurrence undergoing hepatectomy to assess health related quality of life (HRQoL) using the EORTC QLQ-C30, QLQ-LMC21 and the EuroQol EQ-5D-5L, in patients at high risk of recurrence undergoing hepatectomy for colorectal liver metastasis and to evaluate global and disease specific changes over time.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael D'Angelica, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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