BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

NCT04264702 | Unknown

• 1 other identifier: 20-041-NCP
• Study Type: observational
• Target: 1,788
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colon Cancer

Keywords

circulating tumor DNA; BESPOKE

Outcome Measures

Primary Outcomes (2)

• 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.

  1 years

• 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

  2 years

Secondary Outcomes (9)

• Evaluate Molecular residual disease clearance as assessed by SIGNATERA™

  2 years

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

  2 years

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

  2 years

• Explore Overall survival

  2 years

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

  2 years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (1)

San Carlos

San Carlos, California, 94070, United States

Location

Related Publications (1)

• 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.

  PMID: 34561256 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

There are two arms to this study: A prospective arm that will enroll 2000 patients, and a historical control (retrospective arm) that will enroll 600 patients. Each participant in the Prospective arm will have received the commercially available SIGNATERA™ test. Subjects prospectively enrolled and whom consent to "Optional future Research" may have bio-specimens stored for future research. The historical arm (retrospective cohort) will not have any bio-specimens collected or stored.

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alexey Aleshin, MD, MBA

  Natera, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 11, 2020
• Study Start: April 24, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)