BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT04264702|
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : September 22, 2021
|Condition or disease|
|Colorectal Cancer Colon Cancer|
- Examine the impact of SIGNATERA™ on adjuvant treatment decisions
- Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™
- 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]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||January 2025|
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.
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.
- 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
- 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.
Biospecimen Retention: Samples With DNA
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264702
|Contact: Sarah Sawyerfirstname.lastname@example.org|
|United States, California|
|San Carlos, California, United States, 94070|
|Contact: Sarah Sawyer, PhD|
|Principal Investigator:||Alexey Aleshin, MD, MBA||Natera, Inc.|