The CHOICE Registry

August 30, 2024 updated by: Taiho Oncology, Inc.

The CHOICE Registry: A Research Initiative Examining Clinical, Economic, and Humanistic Outcomes in the Management of Metastatic Colorectal Cancer

The CHOICE Registry will describe real-world treatment patterns and physician and patient (and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd line metastatic colorectal cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

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.

Detailed Description

A prospective, non-interventional, observational, approach will be employed. All patient follow-up visits and other interactions will be established by the physician investigator: the CHOICE Registry will not impose a fixed schedule of follow-up visits. Data will be obtained in conjunction with actual follow-up visits to support treatment and various assessments of disease progression, patient quality of life and caregiver burden, and resource utilization. Patients will be followed for minimum of 15 months. All prescribed and administered medications, treatment adjustments and duration will be documented by the physician investigator treating the patient as per standard of care. The CHOICE Registry will not impose any change to the treatment regimen prescribed by physicians participating in the Registry. Adult males and females with metastatic colorectal cancer (having received first and second line treatment, and upon initiation of third line or later treatment) will be eligible to participate. Approximately 1000 patients will be enrolled by approximately 30 to 40 physician investigators representing both community and academic medical centers in the United States. Descriptive statistics will be employed to address the key research objectives of the CHOICE Registry, such as a description of patients receiving various second (and/or subsequent) lines of treatment in the management of metastatic colorectal cancer in real world clinical settings, and the associated clinical, economic, and humanistic (patient-reported) outcomes.

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.
12

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
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from community and academic medical centers in the United States.

Description

Inclusion Criteria:

  1. Age ≥ 18
  2. Diagnosis of metastatic CRC
  3. Having completed first and second lines of treatment for metastatic CRC
  4. Intending (at time of enrollment) to initiate a third (or subsequent) line of treatment
  5. Ability to understand and read English or Spanish
  6. Willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf

Exclusion Criteria:

  1. Patient is unwilling or unable to participate in the Registry at the time of enrollment
  2. The patient is currently participating in an investigational clinical trial
  3. Patients not having mental capacity and or ability to participate in the Registry

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: Other
  • Time Perspectives: Prospective

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
Time Frame
Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
Time Frame: Approximately 15 months
Approximately 15 months
Real-world treatment patterns as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Approximately 15 months
Approximately 15 months
Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L
Time Frame: Approximately 15 months
Approximately 15 months
Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ)
Time Frame: Approximately 15 months
Approximately 15 months
Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI)
Time Frame: Approximately 15 months
Approximately 15 months
Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)
Time Frame: Approximately 15 months
Approximately 15 months
Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.)
Time Frame: Approximately 15 months
Approximately 15 months
Duration of therapy
Time Frame: Approximately 15 months
Approximately 15 months
Reasons for dose adjustments and/or discontinuation of treatments
Time Frame: Approximately 15 months
Approximately 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Healthcare Resource Utilization
Time Frame: Approximately 15 months
To characterize (physician visits, pharmacotherapy, hospitalizations, etc.) in patients receiving various treatment regimens
Approximately 15 months
Quality-of-life of patients receiving specific treatment regimens for mCRC per FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
Time Frame: Approximately 15 months
Approximately 15 months
Quality-of-life of patients receiving specific treatment regimens for mCRC per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Approximately 15 months
Approximately 15 months
Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L
Time Frame: Approximately 15 months
Approximately 15 months
Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ)
Time Frame: Approximately 15 months
Approximately 15 months
Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI)
Time Frame: Approximately 15 months
Approximately 15 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Approximately 15 months
Overall survival is defined as the time from the date of randomization to the date of death
Approximately 15 months
Progression free survival
Time Frame: Approximately 15 months
Progression free survival is defined as the time from the date of randomization until radiological disease
Approximately 15 months

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.
Taiho Oncology, Inc.

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.
June 30, 2017

Primary Completion (Actual)

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.
October 20, 2017

Study Completion (Actual)

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.
December 13, 2017

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).
April 4, 2017

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.
May 8, 2017

First Posted (Actual)

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.
May 10, 2017

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.
September 4, 2024

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.
August 30, 2024

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.
August 1, 2024

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.
  • MA-102-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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