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BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264702
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Natera, Inc.

Tracking Information
First Submitted Date February 4, 2020
First Posted Date February 11, 2020
Last Update Posted Date September 22, 2021
Actual Study Start Date April 24, 2020
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2021)
  • 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.
  • 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
Original Primary Outcome Measures
 (submitted: February 7, 2020)
  • 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
  • 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
Change History
Current Secondary Outcome Measures
 (submitted: September 15, 2021)
  • 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
  • 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
  • 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
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: February 7, 2020)
  • 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 ACT
  • 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
  • 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
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Official Title BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Brief Summary 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.
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 [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:

There are two arms to this study: A prospective arm that will enroll 2000 patients, and a historical control (retrospective arm) that will enroll 600 patients.

Each participant in the Prospective arm will have received the commercially available SIGNATERA™ test.

Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research. The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.

Sampling Method Probability Sample
Study Population Patients who have been diagnosed with Stage I, Stage II, Stage III or Stage IV colorectal cancer.
Condition
  • Colorectal Cancer
  • Colon Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Kasi PM, Sawyer S, Guilford J, Munro M, Ellers S, Wulff J, Hook N, Krinshpun S, Koyen Malashevich A, Malhotra M, Rodriguez A, Moshkevich S, Grothey A, Kopetz S, Billings P, Aleshin A. BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer. BMJ Open. 2021 Sep 24;11(9):e047831. doi: 10.1136/bmjopen-2020-047831.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 15, 2021)
2000
Original Estimated Enrollment
 (submitted: February 7, 2020)
1000
Estimated Study Completion Date January 2025
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sarah Sawyer 650-249-9091 bespokecolonstudy@natera.com
Listed Location Countries United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number NCT04264702
Other Study ID Numbers 20-041-NCP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Natera, Inc.
Original Responsible Party Same as current
Current Study Sponsor Natera, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Alexey Aleshin, MD, MBA Natera, Inc.
PRS Account Natera, Inc.
Verification Date September 2021