Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04264702
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:
NCT04264702
Study Brief:
Protocol Section:
NCT04264702