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

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.

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

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.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Carlos, California, United States, 94070
        • San Carlos

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

Probability Sample

Study Population

Patients who have been diagnosed with Stage I, Stage II, Stage III or Stage IV colorectal cancer.

Description

Inclusion criteria:

  1. 18 years of age or older.
  2. Planning or undergone surgical resection of adenocarcinoma of the colon or rectum.

  3. Diagnosis of Colorectal cancer that falls into one of the below categories:

    1. Stage I to IV disease.
    2. Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
  4. Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice.
  5. ECOG performance status ≤ 2
  6. Clinically eligible for post-operative systemic therapy.
  7. Able to tolerate venipuncture for research blood draw(s).
  8. Able to read, understand and provide written informed consent .
  9. Willing and able to comply with the study requirements.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
  3. Has a known rare inherited genetic condition, with the exception of lynch syndrome
  4. Has initiated post-operative systemic therapy.
  5. Neuropathy > grade 2.
  6. History of bone marrow or organ transplant.
  7. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder .
  8. Serious medical condition that may adversely affect ability to participate in the study.

Control Arm Inclusion criteria:

  1. 18 years of age or older at time of diagnosis.

  2. Diagnosis of Colorectal cancer that falls into one of the below categories:

    1. Stage I to IV disease.
    2. Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
  3. Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider.
  4. Received treatment no more than 3 years prior to study start date.
  5. Have a minimum of least 2 years clinical follow-up data or reached a progression event.

Control Arm Exclusion criteria:

  1. Female patients that were pregnant or breastfeeding during historical control collection period.
  2. Per investigator, was not clinically eligible for post-operative systemic therapy.
  3. 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

Group / Cohort

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

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
Examine the impact of SIGNATERA™ on adjuvant treatment decisions
Time Frame: 1 years
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.
1 years
Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™
Time Frame: 2 years
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
2 years

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
Evaluate Molecular residual disease clearance as assessed by SIGNATERA™
Time Frame: 2 years
The proportion of patients with a positive SIGNATERA™ ctDNA test post-surgery that subsequently receive a negative test result during or after systemic therapy
2 years
The study will examine the percent of patients undergoing surgery for oligometastatic recurrence
Time Frame: 2 years
The proportion of patients that are diagnosed with oligometastatic recurrence that undergo additional surgery
2 years
Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results
Time Frame: 2 years
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
2 years
Explore Overall survival
Time Frame: 2 years
Proportion of patients with a negative SIGNATERA™ ctDNA that are still alive the end of the trial (during surveillance)
2 years
Examine the Impact of SIGNATERA™ test results on patient quality of life
Time Frame: 2 years
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.
2 years
Assess well being in patients receiving SIGNATERA™ ctDNA test results
Time Frame: 2 years
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.
2 years
Assess patient cancer anxiety levels in patients receiving SIGNATERA™ ctDNA test results
Time Frame: 2 years
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.
2 years
Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results
Time Frame: 2 years
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.
2 years
Examine the number of Stage I CRC patients that have recurrent disease detected post-surgery based on SIGNATERA™ test results
Time Frame: 2 years
Proportion of Stage I CRC cases with a positive SIGNATERA™ test and have recurrent disease detected post-surgery and receive systemic therapy.
2 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.
Natera, Inc.

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: 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.

General Publications

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.
April 24, 2020

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.
September 1, 2025

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.
September 1, 2025

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).
February 4, 2020

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.
February 7, 2020

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.
February 11, 2020

Study Record Updates

Last Update Posted (Estimated)

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.
December 12, 2023

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.
December 11, 2023

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.
December 1, 2023

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.
  • 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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