Metastatic Colorectal CancerNCT03148093
The CHOICE Registry
An observational study of Metastatic Colorectal Cancer, run by Taiho Oncology, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 13 Dec 2017
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from community and academic medical centers in the United States.
Who may be able to join
- Age ≥ 18
- Diagnosis of metastatic CRC
- Having completed first and second lines of treatment for metastatic CRC
- Intending (at time of enrollment) to initiate a third (or subsequent) line of treatment
- Ability to understand and read English or Spanish
- 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
Who cannot join
- Patient is unwilling or unable to participate in the Registry at the time of enrollment
- The patient is currently participating in an investigational clinical trial
- Patients not having mental capacity and or ability to participate in the Registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer, Registry, Patient Reported Outcomes, Treatment Patterns, Prescription Use
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
Measured: 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)
Measured: Approximately 15 months
Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L
Measured: Approximately 15 months
Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ)
Measured: Approximately 15 months
Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI)
Measured: Approximately 15 months
Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)
Measured: Approximately 15 months
Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.)
Measured: Approximately 15 months
Duration of therapy
Measured: Approximately 15 months
Reasons for dose adjustments and/or discontinuation of treatments
Measured: Approximately 15 months
Secondary outcomes (6)
Healthcare Resource Utilization
To characterize (physician visits, pharmacotherapy, hospitalizations, etc.) in patients receiving various treatment regimens
Measured: Approximately 15 months
Quality-of-life of patients receiving specific treatment regimens for mCRC per FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
Measured: 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)
Measured: Approximately 15 months
Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L
Measured: Approximately 15 months
Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ)
Measured: Approximately 15 months
Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI)
Measured: Approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start30 Jun 2017
- Primary completion20 Oct 2017
- Study completion13 Dec 2017
Why it stopped: Competing clinical trials and slower than expected patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148093
- Sponsor's protocol ID
- MA-102-01
- Status last verified
- Aug 2024
- First submitted
- 4 Apr 2017
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHOICE Registry: A Research Initiative Examining Clinical, Economic, and Humanistic Outcomes in the Management of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03148093
- Acronym / sponsor ID
- MA-102-01
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer, Registry, Patient Reported Outcomes, Treatment Patterns, Prescription Use
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Competing clinical trials and slower than expected patient enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 15 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from community and academic medical centers in the United States.
Key inclusion criteria (6 listed)
- Age ≥ 18
- Diagnosis of metastatic CRC
- Having completed first and second lines of treatment for metastatic CRC
- Intending (at time of enrollment) to initiate a third (or subsequent) line of treatment
- Ability to understand and read English or Spanish
Key exclusion criteria (3 listed)
- Patient is unwilling or unable to participate in the Registry at the time of enrollment
- The patient is currently participating in an investigational clinical trial
- Patients not having mental capacity and or ability to participate in the Registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)
Time frame: 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
Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L
Time frame: Approximately 15 months
Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ)
Time frame: Approximately 15 months
Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI)
Time frame: Approximately 15 months
Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)
Time frame: Approximately 15 months
Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.)
Time frame: Approximately 15 months
Duration of therapy
Time frame: Approximately 15 months
Reasons for dose adjustments and/or discontinuation of treatments
Time frame: Approximately 15 months
6 secondary outcomes
Healthcare Resource Utilization
Time frame: 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
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
Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L
Time frame: Approximately 15 months
Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ)
Time frame: 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
Results and safety
The study was stopped early (reason given: Competing clinical trials and slower than expected patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Taiho Oncology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Competing clinical trials and slower than expected patient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19) (time frame: Approximately 15 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.