Status:
COMPLETED
Relapse Markers for Colorectal Cancer
Lead Sponsor:
Novigenix SA
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT04920955
Start Date
February 10 2021
End Date
January 31 2024
Last Update
March 19 2024
Active Locations (1)
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1
Department of Gastroenterology, Digestive Oncology Unit
Leuven, Belgium