BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
NCT ID: NCT04264702
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1788 participants
OBSERVATIONAL
2020-04-24
2025-09-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Prospective arm
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 adjuvant chemotherapy or observation by their treating clinician. Patients will be followed for up to two years with periodic whole blood collection. Treatment administered, disease-free survival, overall survival, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded.
No interventions assigned to this group
Control Arm
The control arm will consist of matched Stage I to Stage IV CRC cases using the following criteria: sex, age of diagnosis and ECOG performance prior to ACT, and a minimum of 3 evaluations per year. The patient cases would have a minimum of 2 years follow-up data and received treatment no more than 3 years prior to study start date.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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 .
9. Willing and able to comply with the study requirements.
1. 18 years of age or older at time of diagnosis.
2. 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.
3. Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider.
4. Received treatment no more than 3 years prior to study start date.
5. Have a minimum of least 2 years clinical follow-up data or reached a progression event.
Exclusion Criteria
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.
3. Had an ECOG performance status ≤ 2 at time of diagnosis.
18 Years
ALL
No
Sponsors
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Natera, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alexey Aleshin, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Natera, Inc.
Locations
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San Carlos
San Carlos, California, United States
Countries
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References
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Kasi PM, Sawyer S, Guilford J, Munro M, Ellers S, Wulff J, Hook N, Krinshpun S, Koyen Malashevich A, Malhotra M, Rodriguez A, Moshkevich S, Grothey A, Kopetz S, Billings P, Aleshin A. BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer. BMJ Open. 2021 Sep 24;11(9):e047831. doi: 10.1136/bmjopen-2020-047831.
Other Identifiers
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20-041-NCP
Identifier Type: -
Identifier Source: org_study_id