Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04264702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2020-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Sponsor:
Natera, Inc.
Organization:
Study Overview
Official Title:
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: