BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    Natera, Inc.
Send
Updated on 16 February 2024
See if I qualify
cancer
formalin-fixed paraffin-embedded
adenocarcinoma
adjuvant chemotherapy
adenocarcinoma of colon
adenocarcinoma of the colon
adjuvant
colorectal cancer

Summary

The BESPOKE CRC study will prospectively enroll patients who have undergone surgery for stage II or III 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 adjuvant chemotherapy 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 II or Stage III CRC cases that have a minimum of least 2 years clinical follow-up data.

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

Details
Condition Colorectal Cancer, Colorectal Cancer, Rectal disorder, Malignant neoplasm of colon
Age 18years - 100years
Clinical Study IdentifierNCT04264702
SponsorNatera, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

18 years of age or older at time of diagnosis
Pathologic stage II or III colorectal cancer
Had an ECOG performance status 2 at time of diagnosis
Were clinically eligible for chemotherapy at full recommended doses per investigator
Received treatment no more than 3 years prior to study start date
Have a minimum of least 2 years clinical follow-up data

Exclusion Criteria

Female patients that were pregnant or breastfeeding during historical control collection period
Radiologic evidence of distant metastases
Per investigator, was not clinically eligible for systemic chemotherapy
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer
formalin-fixed paraffin-embedded
adenocarcinoma
adjuvant chemotherapy
adenocarcinoma of colon
adenocarcinoma of the colon
adjuvant
colorectal cancer

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.