RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT04264702 BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Status

Open

Description

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.

Objective

The primary objectives are to examine the impact of SIGNATERA on adjuvant treatment decisions and to Determine the rate of patient s diagnosed with CRC recurrence while asymptomatic using SIGNATERA.

Treatment

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.

Conditions

Anus; Colon; Small Intestine; Stomach

Phases

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Landmann, Ron

Practice

GI

Scope

National

Participating Institutions

BMDACC Clinical Trials Office

Eligibility

Inclusion criteria: 1.18 years of age or older 2.Planning or undergone surgical resection of 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 routine practice 5.ECOG performance status LESS THAN OR EQUAL TO 2 6.Clinically eligible for chemotherapy 7.Able to tolerate collection of up to 20 mL of blood via 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.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.Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder 9.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.Were clinically eligible for chemotherapy at full recommended doses per investigator 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 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 4.Had an ECOG performance status LESS Than or EQUAL TO 2 at time of diagnosis

Nct ID Number

NCT04264702

Secondary Trial ID Number

20-041-NCP

Keywords

Observational

More Information

clinicaltrials.gov

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