- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264702
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
December 11, 2023 updated by: Natera, Inc.
The BESPOKE CRC study will prospectively enroll patients who have undergone surgery for stage I to IV colorectal cancer (CRC) and who have residual formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole blood samples.
Patients will receive SIGNATERA™ test results and may be recommended for post-operative systemic therapy or observation by their treating clinician.
Patients will be followed for up to two years with periodic whole blood collection.
The study also has a control arm that will consist of matched Stage I to IV CRC cases that have a minimum of least 2 years clinical follow-up data.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Primary Objectives:
- Examine the impact of SIGNATERA™ on adjuvant treatment decisions
- Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™
Secondary objectives:
- Molecular residual disease clearance as assessed by SIGNATERA™
- Percent of patients undergoing surgery for oligometastatic recurrence
- Survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results
- Overall survival
- Impact of SIGNATERA™ test results on patient quality of life
Study Type
Observational
Enrollment (Actual)
1788
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
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California
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San Carlos, California, United States, 94070
- San Carlos
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who have been diagnosed with Stage I, Stage II, Stage III or Stage IV colorectal cancer.
Description
Inclusion criteria:
- 18 years of age or older.
- Planning or undergone surgical resection of adenocarcinoma of the colon or rectum.
Diagnosis of Colorectal cancer that falls into one of the below categories:
- Stage I to IV disease.
- Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
- Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice.
- ECOG performance status ≤ 2
- Clinically eligible for post-operative systemic therapy.
- Able to tolerate venipuncture for research blood draw(s).
- Able to read, understand and provide written informed consent .
- Willing and able to comply with the study requirements.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
- Has a known rare inherited genetic condition, with the exception of lynch syndrome
- Has initiated post-operative systemic therapy.
- Neuropathy > grade 2.
- History of bone marrow or organ transplant.
- Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder .
- Serious medical condition that may adversely affect ability to participate in the study.
Control Arm Inclusion criteria:
- 18 years of age or older at time of diagnosis.
Diagnosis of Colorectal cancer that falls into one of the below categories:
- Stage I to IV disease.
- Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
- Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider.
- Received treatment no more than 3 years prior to study start date.
- Have a minimum of least 2 years clinical follow-up data or reached a progression event.
Control Arm Exclusion criteria:
- Female patients that were pregnant or breastfeeding during historical control collection period.
- Per investigator, was not clinically eligible for post-operative systemic therapy.
- Had an ECOG performance status ≤ 2 at time of diagnosis.
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: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Prospective arm
Patients who have undergone surgery for stage I to IV colorectal cancer (CRC) and who have residual formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole blood samples.
Patients will receive SIGNATERA™ test results and may be recommended for adjuvant chemotherapy or observation by their treating clinician.
Patients will be followed for up to two years with periodic whole blood collection.
Treatment administered, disease-free survival, overall survival, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded.
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Control Arm
The control arm will consist of matched Stage I to Stage IV CRC cases using the following criteria: sex, age of diagnosis and ECOG performance prior to ACT, and a minimum of 3 evaluations per year.
The patient cases would have a minimum of 2 years follow-up data and received treatment no more than 3 years prior to study start date.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine the impact of SIGNATERA™ on adjuvant treatment decisions
Time Frame: 1 years
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The study will examine the percent of patients who have their adjuvant treatment regimen increased or decreased after the treating physician evaluates the results from the post-surgical SIGNATERA™ ctDNA test for patients with Stage II and Stage III CRC.
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1 years
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Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™
Time Frame: 2 years
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The study will examine the Proportion of positive SIGNATERA™ results at any timepoint during surveillance; prior to being identified by other methods whilst undergoing recurrence monitoring for patients with Stage I to IV CRC
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate Molecular residual disease clearance as assessed by SIGNATERA™
Time Frame: 2 years
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The proportion of patients with a positive SIGNATERA™ ctDNA test post-surgery that subsequently receive a negative test result during or after systemic therapy
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2 years
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The study will examine the percent of patients undergoing surgery for oligometastatic recurrence
Time Frame: 2 years
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The proportion of patients that are diagnosed with oligometastatic recurrence that undergo additional surgery
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2 years
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Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results
Time Frame: 2 years
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Proportion of patients with a negative SIGNATERA™ ctDNA test post-surgery that are still alive the end of the trial (during surveillance) treated with adjuvant versus no adjuvant chemotherapy
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2 years
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Explore Overall survival
Time Frame: 2 years
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Proportion of patients with a negative SIGNATERA™ ctDNA that are still alive the end of the trial (during surveillance)
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2 years
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Examine the Impact of SIGNATERA™ test results on patient quality of life
Time Frame: 2 years
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Determine if SIGNATERA™ results makes patients feel less worried or anxious about the possibility of cancer recurrence.
Assess if SIGNATERA™ makes patients feel that they are receiving the right treatment and determine if patients would continue to use Signatera in the future to monitor their cancer recurrence.
This will be measured by asking the patients three study specific questions on a 5-point scale (1=Not all, 5= All the time) with a lower score indicating a better outcome.
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2 years
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Assess well being in patients receiving SIGNATERA™ ctDNA test results
Time Frame: 2 years
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Assess a patients wellbeing using the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index- 19 items (NCCN-FACT FCIS-19 version 2).
Responses for each items are given on a 4-point scale (0=Not at all, 4 = very much) with a lower score indicating a better outcome.
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2 years
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Assess patient cancer anxiety levels in patients receiving SIGNATERA™ ctDNA test results
Time Frame: 2 years
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Assess Fear of Recurrence in patients receiving SIGNATERA™ ctDNA test results by using the Fear of Recurrence short form (FCR-4) using a 5-point scale (1=Not all, 5= All the time) with a lower score indicating a better outcome.
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2 years
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Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results
Time Frame: 2 years
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Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results using the Hospital Anxiety and Depression Scale (HADS-A).
The HADS is a fourteen item scale.
Seven of the items relate to anxiety and seven relate to depression.
The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
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2 years
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Examine the number of Stage I CRC patients that have recurrent disease detected post-surgery based on SIGNATERA™ test results
Time Frame: 2 years
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Proportion of Stage I CRC cases with a positive SIGNATERA™ test and have recurrent disease detected post-surgery and receive systemic therapy.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexey Aleshin, MD, MBA, Natera, Inc.
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.
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)
April 24, 2020
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 7, 2020
First Posted (Actual)
February 11, 2020
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-041-NCP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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