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BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Status
Closed
Cancer Type
Colon/Rectal Cancer
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCT ID
NCT04264702
Protocol IDs
20-041-NCP (primary)
NCI-2020-03933
Study Sponsor
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.

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

Eligibility

  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:
  4. Stage I to IV disease.
  5. Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
  6. Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice.
  7. ECOG performance status = 2
  8. Clinically eligible for post-operative systemic therapy.
  9. Able to tolerate venipuncture for research blood draw(s).
  10. Able to read, understand and provide written informed consent .
  11. Willing and able to comply with the study requirements.

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

**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.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.