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Trial record 1 of 1 for:    20-041-NCP
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BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04264702
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Natera, Inc.

Brief 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.

Condition or disease
Colorectal Cancer Colon Cancer

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Prospective arm
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. 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 II or Stage III 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.



Primary Outcome Measures :
  1. Examine the impact of SIGNATERA™ on adjuvant treatment decisions [ Time Frame: 1 years ]
    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

  2. Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™ [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Evaluate Molecular residual disease clearance as assessed by SIGNATERA™ [ Time Frame: 2 years ]
    The proportion of patients with a positive SIGNATERA™ ctDNA test post-surgery that subsequently receive a negative test result during or after ACT

  2. The study will examine the percent of patients undergoing surgery for oligometastatic recurrence [ Time Frame: 2 years ]
    The proportion of patients that are diagnosed with oligometastatic recurrence that undergo additional surgery

  3. Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results [ Time Frame: 2 years ]
    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

  4. Explore Overall survival [ Time Frame: 2 years ]
    Proportion of patients with a negative SIGNATERA™ ctDNA that are still alive the end of the trial (during surveillance)

  5. Examine the Impact of SIGNATERA™ test results on patient quality of life [ Time Frame: 2 years ]
    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.

  6. Assess well being in patients receiving SIGNATERA™ ctDNA test results [ Time Frame: 2 years ]
    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.

  7. Assess patient cancer anxiety levels in patients receiving SIGNATERA™ ctDNA test results [ Time Frame: 2 years ]
    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.

  8. Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results [ Time Frame: 2 years ]
    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.


Biospecimen Retention:   Samples With DNA

There are two arms to this study: A prospective arm that will enroll 1000 patients, and a historical control (retrospective arm) that will enroll 300 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have been diagnosed with Stage II or III colorectal cancer
Criteria

Inclusion criteria:

  1. 18 years of age or older
  2. Surgically resected adenocarcinoma of the colon or rectum
  3. Pathologic stage II or III disease
  4. Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their standard of practice
  5. ECOG performance status ≤ 2
  6. Clinically eligible for chemotherapy
  7. Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
  8. Has residual FFPE specimen available for submission to Natera
  9. Able to read, understand and provide written informed consent
  10. Willing and able to comply with the study requirements

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Radiologic evidence of distant metastases
  3. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
  4. Has a known rare inherited genetic condition, with the exception of lynch syndrome
  5. Has initiated adjuvant chemotherapy
  6. Neuropathy > grade 2
  7. History of bone marrow or organ transplant
  8. Blood transfusion within 1 month of enrollment
  9. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
  10. 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. Pathologic stage II or III colorectal cancer
  3. Had an ECOG performance status ≤ 2 at time of diagnosis
  4. Were clinically eligible for chemotherapy at full recommended doses per investigator
  5. Received treatment no more than 3 years prior to study start date
  6. Have a minimum of least 2 years clinical follow-up data

Control Arm Exclusion criteria:

  1. Female patients that were pregnant or breastfeeding during historical control collection period
  2. Radiologic evidence of distant metastases
  3. Per investigator, was not clinically eligible for systemic chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264702


Contacts
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Contact: Sarah Sawyer 650-249-9091 bespokecolonstudy@natera.com

Locations
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United States, California
Stockton Hematology Oncology Medical Group Recruiting
Stockton, California, United States, 95204
Contact: Ajithkumar Puthillath, MD         
United States, Florida
Oncology & Hematology Associates of West Broward Recruiting
Tamarac, Florida, United States, 33321
Contact: Sumit Sawhney, MD         
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Ahad Sadiq, MD         
United States, Louisiana
Pontchartrain Cancer Center Recruiting
Covington, Louisiana, United States, 70433
Contact: David Oubre, MD         
United States, New Jersey
New Jersey Cancer Care Recruiting
Belleville, New Jersey, United States, 07109
Contact: James Orsini, MD         
United States, Ohio
The Toledo Clinic Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat, MD         
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Byron Jennings, MD         
United States, Oregon
Oregon Oncology Specialists Recruiting
Salem, Oregon, United States, 97301
Contact: Janelle Meyer, MD         
United States, South Carolina
Carolina Blood and Cancer Care Associates Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Niyati Nathwani, MD         
United States, Virginia
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23226
Contact: Nathan Langer, MD         
United States, Washington
Summit Cancer Centers Recruiting
Spokane, Washington, United States, 99208
Contact: Arvind Chaudhry, MD         
Northwest Medical Recruiting
Tacoma, Washington, United States, 98405
Contact: Jorge Chaves, MD         
Sponsors and Collaborators
Natera, Inc.
Investigators
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Principal Investigator: Alexey Aleshin, MD, MBA Natera, Inc.
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Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT04264702    
Other Study ID Numbers: 20-041-NCP
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natera, Inc.:
circulating tumor DNA
BESPOKE
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases