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BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer | Clinical Trials | Clareo Health

UNKNOWN

BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

NCT04264702•Natera, Inc.

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 .
+8 more criteria

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.
•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.
+1 more criteria

Locations (1)

San Carlos

San Carlos, California, United States

Key Dates

Start Date

April 24, 2020

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

December 12, 2023

Enrollment

1,788

ACTUAL participants

Conditions

Colorectal CancerColon Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)