BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Active:	No
Cancer Type:	Colon/Rectal Cancer Unknown Primary	NCT ID:	NCT04264702
Trial Phases:		Protocol IDs:	20-041-NCP (primary) NCI-2020-03933
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Natera, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04264702

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.

Objectives

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

Treatment Sites in Georgia

Central Georgia Cancer Care, PC - Macon
800 First Street
Suite 410
Macon, GA 31201
478-743-7068
www.centralGeorgiacancercare.com

Harbin Clinic Cancer Center
255 West Fifth Street
Rome, GA 30165
706-528-9110
www.harbinclinic.com

John B Amos Cancer Center
1831 Fifth Avenue
Columbus, GA 31904
706-780-6201

Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

Pearlman Cancer Center at South Georgia Medical Center
2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org

Phoebe Cancer Center at Phoebe Putney Memorial Hospital
425 Third Avenue
Albany, GA 31702
(229) 312-0406
www.phoebehealth.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.