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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04920955
Other study ID # S64663
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2021
Est. completion date January 31, 2024

Study information

Verified date March 2024
Source Novigenix SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date January 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Department of Gastroenterology, Digestive Oncology Unit Leuven

Sponsors (1)

Lead Sponsor Collaborator
Novigenix SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity for relapse detection Sensitivity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method Relapse occurring within 5 years from primary curative intervention
Primary Specificity for relapse detection Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method 36 months disease-free
Secondary Concordance analyses Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points 24 months
Secondary Test positivity Estimation of the multi-marker test positivity for all patients and time points 24 months
Secondary Coefficient of variation of the biomarkers Intra- and inter-individual coefficient of variation of the biomarkers, pre- and post-surgery and during surveillance up to relapse 6 weeks
Secondary Sensitivity for CRC detection Sensitivity of the test for detection of primary CRC up to 1 day prior to tumor resection
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