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Colorectal CancerNCT04264702

BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

An observational study of Colorectal Cancer and Colon Cancer, run by Natera, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Colon Cancer
Type of treatment
Injection or infusion
How many people
1,788 participants
Where
1 siteUnited States
Study dates
24 Apr 2020to Sep 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who have been diagnosed with Stage I, Stage II, Stage III or Stage IV colorectal cancer.

Who may be able to join

  • 18 years of age or older.
  • Planning or undergone surgical resection of adenocarcinoma of the colon or rectum.
  • Diagnosis of Colorectal cancer that falls into one of the below categories:
  • Stage I to IV disease.
  • Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
  • Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice.
Show all 11Show fewer
  • ECOG performance status ≤ 2
  • Clinically eligible for post-operative systemic therapy.
  • Able to tolerate venipuncture for research blood draw(s).
  • Able to read, understand and provide written informed consent .
  • Willing and able to comply with the study requirements.

Who cannot join

  • Pregnant or breastfeeding.
  • Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
  • Has a known rare inherited genetic condition, with the exception of lynch syndrome
  • Has initiated post-operative systemic therapy.
  • Neuropathy > grade 2.
  • History of bone marrow or organ transplant.
Show all 20Show fewer
  • Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder .
  • Serious medical condition that may adversely affect ability to participate in the study.
  • Control Arm Inclusion criteria:
  • 18 years of age or older at time of diagnosis.
  • Diagnosis of Colorectal cancer that falls into one of the below categories:
  • Stage I to IV disease.
  • Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
  • Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider.
  • Received treatment no more than 3 years prior to study start date.
  • Have a minimum of least 2 years clinical follow-up data or reached a progression event.
  • Control Arm Exclusion criteria:
  • Female patients that were pregnant or breastfeeding during historical control collection period.
  • Per investigator, was not clinically eligible for post-operative systemic therapy.
  • Had an ECOG performance status ≤ 2 at time of diagnosis.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Carlos

    San Carlos, California, 94070

Other trials in United States

About this study

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.

Read the 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
Keywords
circulating tumor DNA, BESPOKE
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04264702
Study groupRoleWhat they receive
Prospective armPatients 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.
Control ArmThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Examine the impact of SIGNATERA™ on adjuvant treatment decisions

    The study will examine the percent of patients who have their adjuvant treatment regimen increased or decreased after the treating physician evaluates the results from the post-surgical SIGNATERA™ ctDNA test for patients with Stage II and Stage III CRC.

    Measured: 1 years

  2. Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™

    The study will examine the Proportion of positive SIGNATERA™ results at any timepoint during surveillance; prior to being identified by other methods whilst undergoing recurrence monitoring for patients with Stage I to IV CRC

    Measured: 2 years

Secondary outcomes (9)

  1. Evaluate Molecular residual disease clearance as assessed by SIGNATERA™

    The proportion of patients with a positive SIGNATERA™ ctDNA test post-surgery that subsequently receive a negative test result during or after systemic therapy

    Measured: 2 years

  2. The study will examine the percent of patients undergoing surgery for oligometastatic recurrence

    The proportion of patients that are diagnosed with oligometastatic recurrence that undergo additional surgery

    Measured: 2 years

  3. Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results

    Proportion of patients with a negative SIGNATERA™ ctDNA test post-surgery that are still alive the end of the trial (during surveillance) treated with adjuvant versus no adjuvant chemotherapy

    Measured: 2 years

  4. Explore Overall survival

    Proportion of patients with a negative SIGNATERA™ ctDNA that are still alive the end of the trial (during surveillance)

    Measured: 2 years

  5. Examine the Impact of SIGNATERA™ test results on patient quality of life

    Determine if SIGNATERA™ results makes patients feel less worried or anxious about the possibility of cancer recurrence. Assess if SIGNATERA™ makes patients feel that they are receiving the right treatment and determine if patients would continue to use Signatera in the future to monitor their cancer recurrence. This will be measured by asking the patients three study specific questions on a 5-point scale (1=Not all, 5= All the time) with a lower score indicating a better outcome.

    Measured: 2 years

  6. Assess well being in patients receiving SIGNATERA™ ctDNA test results

    Assess a patients wellbeing using the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index- 19 items (NCCN-FACT FCIS-19 version 2). Responses for each items are given on a 4-point scale (0=Not at all, 4 = very much) with a lower score indicating a better outcome.

    Measured: 2 years

  7. Assess patient cancer anxiety levels in patients receiving SIGNATERA™ ctDNA test results

    Assess Fear of Recurrence in patients receiving SIGNATERA™ ctDNA test results by using the Fear of Recurrence short form (FCR-4) using a 5-point scale (1=Not all, 5= All the time) with a lower score indicating a better outcome.

    Measured: 2 years

  8. Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results

    Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results using the Hospital Anxiety and Depression Scale (HADS-A). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

    Measured: 2 years

  9. Examine the number of Stage I CRC patients that have recurrent disease detected post-surgery based on SIGNATERA™ test results

    Proportion of Stage I CRC cases with a positive SIGNATERA™ test and have recurrent disease detected post-surgery and receive systemic therapy.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start24 Apr 2020
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,788 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264702
Sponsor's protocol ID
20-041-NCP
Status last verified
Dec 2023
First submitted
4 Feb 2020
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34561256

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Colon Cancer, run by Natera, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Examine the impact of SIGNATERA™ on adjuvant treatment decisions (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264702, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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