NCT04264702进行中（未招募）不适用
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Natera, Inc.
- 入组人数
- 1,788
- 试验地点
- 1
- 主要终点
- Examine the impact of SIGNATERA™ on adjuvant treatment decisions
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
- •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.
- •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.
结局指标
主要结局
Examine the impact of SIGNATERA™ on adjuvant treatment decisions
时间窗: 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 for patients with Stage II and Stage III CRC.
Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™
时间窗: 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 for patients with Stage I to IV CRC
次要结局
- Explore Overall survival(2 years)
- Examine the Impact of SIGNATERA™ test results on patient quality of life(2 years)
- The study will examine the percent of patients undergoing surgery for oligometastatic recurrence(2 years)
- Assess patient anxiety and depression levels in patients receiving SIGNATERA™ ctDNA test results(2 years)
- Examine the number of Stage I CRC patients that have recurrent disease detected post-surgery based on SIGNATERA™ test results(2 years)
- Evaluate Molecular residual disease clearance as assessed by SIGNATERA™(2 years)
- Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results(2 years)
- Assess well being in patients receiving SIGNATERA™ ctDNA test results(2 years)
- Assess patient cancer anxiety levels in patients receiving SIGNATERA™ ctDNA test results(2 years)
研究者
研究点 (1)
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相关资讯
ctDNA-Guided Adjuvant Therapy in Colorectal Cancer: BESPOKE CRC and the Promise of Next-Generation Drugs- Nicholas Hornstein, MD, PhD, highlights that positive ctDNA after colorectal cancer surgery signals an overwhelming likelihood of recurrence despite clean imaging and normal CEA.
- The BESPOKE CRC study is reshaping clinical practice by examining ctDNA-guided adjuvant therapy decision-making for patients with stage II colorectal cancer.
- Hornstein argues that current approved agents are insufficient to change disease trajectory, and the real clinical transformation will come from next-generation drugs now in phase 2 and 3 trials.
- A c-MET inhibitor showed a 23% overall response rate in heavily pretreated metastatic colorectal cancer, while a RAS inhibitor plus PRMT5 inhibitor combination demonstrated over 90% disease control in pancreatic cancer.2 months agoctDNA Testing Shows Promise in Guiding Colorectal Cancer Treatment Decisions- ctDNA testing influenced adjuvant therapy decisions in 16.3% of stage II/III colorectal cancer cases, with de-escalation in 59.9% and escalation in 35.7%.
- Post-operative ctDNA positivity predicts inferior disease-free survival, while ctDNA clearance is associated with superior outcomes in stage II/III CRC.
- ctDNA testing demonstrates high sensitivity in detecting recurrence across various sites, including low-shedding areas like the peritoneum and lung.
- Adjuvant chemotherapy benefit was evident only in MRD-positive patients, highlighting ctDNA's potential for treatment selection in stage II/III CRC.last year