Clinical trial NCT04920955: Relapse Markers for Colorectal Cancer
Official title: Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Novigenix SA
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll CRC patients into 4 study groups. G1: patients with an actual diagnosis of CRC relapse. G2: patients declared disease-free for at least 36 months but less than 5 years.

G3: stage III-IV CRC patients who underwent a curative treatment and are disease-free after primary treatment for more than 3 but less than 18 months.

G4: patients diagnosed with primary CRC without any cancer treatment.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity for relapse detection
timeFrame: Relapse occurring within 5 years from primary curative intervention
measure: Specificity for relapse detection
timeFrame: 36 months disease-free
Secondary outcomes:
measure: Concordance analyses
timeFrame: 24 months
measure: Test positivity
timeFrame: 24 months
measure: Coefficient of variation of the biomarkers
timeFrame: 6 weeks
measure: Sensitivity for CRC detection
timeFrame: up to 1 day prior to tumor resection
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Gastroenterology, Digestive Oncology Unit
Study officials:
affiliation: Novigenix SA
name: Laura Ciarloni
role: STUDY_DIRECTOR
affiliation: UZ Leuven
name: Sabine Tejpar
role: PRINCIPAL_INVESTIGATOR
References: