BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Active, not recruiting

• Conditions: Colorectal Cancer; Colon Cancer

• Registration Number: NCT04264702
• Lead Sponsor: Natera, Inc.

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 Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Study Start: 2020-04-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1788

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine the impact of SIGNATERA™ on adjuvant treatment decisions	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™	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

Secondary Outcome Measures

Name	Time	Method
Explore Overall survival	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	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.
Examine the number of Stage I CRC patients that have recurrent disease detected post-surgery based on SIGNATERA™ test results	2 years	Proportion of Stage I CRC cases with a positive SIGNATERA™ test and have recurrent disease detected post-surgery and receive systemic therapy.
Evaluate Molecular residual disease clearance as assessed by SIGNATERA™	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
Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results	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
Assess well being in patients receiving SIGNATERA™ ctDNA test results	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	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.
The study will examine the percent of patients undergoing surgery for oligometastatic recurrence	2 years	The proportion of patients that are diagnosed with oligometastatic recurrence that undergo additional surgery
Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results	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.

Trial Locations

Locations (1)

San Carlos; 🇺🇸 San Carlos, California, United States