Clinical trial NCT04264702: BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Official title: BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Colon Cancer
Keywords: circulating tumor DNA
BESPOKE
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 1788
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with Stage I, Stage II, Stage III or Stage IV colorectal cancer.

Brief 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 criteria: 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 .
9. Willing and able to comply with the study requirements.

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.

Control Arm Inclusion criteria:

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.

Control Arm Exclusion criteria:

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.

Primary outcomes:
measure: Examine the impact of SIGNATERA™ on adjuvant treatment decisions
timeFrame: 1 years
measure: Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate Molecular residual disease clearance as assessed by SIGNATERA™
timeFrame: 2 years
measure: The study will examine the percent of patients undergoing surgery for oligometastatic recurrence
timeFrame: 2 years
measure: Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results
timeFrame: 2 years
measure: Explore Overall survival
timeFrame: 2 years
measure: Examine the Impact of SIGNATERA™ test results on patient quality of life
timeFrame: 2 years
measure: Assess well being in patients receiving SIGNATERA™ ctDNA test results
timeFrame: 2 years
measure: Assess patient cancer anxiety levels in patients receiving SIGNATERA™ ctDNA test results
timeFrame: 2 years
measure: Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results
timeFrame: 2 years
measure: Examine the number of Stage I CRC patients that have recurrent disease detected post-surgery based on SIGNATERA™ test results
timeFrame: 2 years
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: San Carlos
state: California
Study officials:
affiliation: Natera, Inc.
name: Alexey Aleshin, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.