NCT04920955CompletedNot Applicable
Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse
Novigenix SA1 site in 1 country264 target enrollmentStarted: February 10, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- Sensitivity for relapse detection
Study Overview
Brief Summary
This is an observational case-control study which enroll metastatic and non-metastatic colorectal cancer (CRC) patients. The objective of this study is to evaluate a novel blood multi-marker test for the detection of relapse in colorectal cancer patients. This test is based on whole-blood transcriptomic signatures and circulating tumor methylated DNA markers. The patients will be enrolled into 4 study groups, two cross-sectional and two longitudinal groups, to follow up patients up to 36 months from primary tumor resection.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female ≥ 18 years of age at time of informed consent.
- •Subject has signed the informed consent form (ICF) and is able to understand the information provided in it.
- •At least a blood sample is collected per subject according to the sample collection protocol.
- •Patients enrolled in local prospective protocols, in which samples have been collected according the study procedures may be included.
- •Group 1: patients with a radiologically and, whenever is possible, histologically confirmed relapse (local or distant) of colorectal cancer within 5 years from primary surgery. Metachronous primary tumors are not considered as relapse and should be excluded.
- •Group 2: Patients declared disease-free for at least 36 months but less than 5 years, as confirmed by radiological examination.
- •Group 3: Patients with a stage III-IV colorectal cancer with a curative treatment and disease-free for at least 3 months but less than 18 months.
- •Group 4: Histologically and radiologically confirmed diagnosis of stage I, II, III or IV colorectal adenocarcinoma, eligible for a treatment with curative intent.
Exclusion Criteria
- •Personal history of cancer (non-hematologic) other than CRC in complete remission for less than 5 years.
- •Personal history of hematologic cancer.
- •A blood transfusion within 6 weeks prior to inclusion into the study.
- •Transplant with regular intake of immunosuppressants.
- •Pregnant woman (self-declaration).
- •Conditions or comorbidities that would preclude the compliance with the planned surveillance program or with the protocol as judged by the Investigator.
- •Previous inclusion in the RELMA-C study and/or re-inclusion in a different study group.
- •Group 1: Any treatment for CRC relapse prior to blood collection.
- •Group 2: Patient is disease-free for less than 36 months or more than 5 years.
- •Group 3: Patient is disease-free for less than 3 months or more than 18 months
- •Group 3: Stage IV patients with detectable residual disease after primary treatment.
- •Group 4: Any cancer treatment prior to blood collection.
Outcomes
Primary Outcomes
Sensitivity for relapse detection
Time Frame: Relapse occurring within 5 years from primary curative intervention
Sensitivity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method
Specificity for relapse detection
Time Frame: 36 months disease-free
Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method
Secondary Outcomes
- Coefficient of variation of the biomarkers(6 weeks)
- Concordance analyses(24 months)
- Test positivity(24 months)
- Sensitivity for CRC detection(up to 1 day prior to tumor resection)
Investigators
Study Sites (1)
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