NCT04920955Completed
Relapse Markers for Colorectal Cancer
Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse
Source: ClinicalTrials.gov · Last updated 19 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 264 (actual)
- First submitted
- 2 Jun 2021
- Start date
- 10 Feb 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Novigenix SA
- Diseases
- Colorectal cancer
- NCT number
- NCT04920955
What you commit to
- Study type: Observational
- Participants enrolled: 264
- From 10 Feb 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A blood transfusion within 6 weeks prior to inclusion into the study.
- Transplant with regular intake of immunosuppressants.
- 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 4: Any cancer treatment prior to blood collection.
Other illness
- Personal history of cancer (non-hematologic) other than CRC in complete remission for less than 5 years.
- Personal history of hematologic cancer.
- Conditions or comorbidities that would preclude the compliance with the planned surveillance program or with the protocol as judged by the Investigator.
- 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.
Other
- Pregnant woman (self-declaration).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology, Digestive Oncology Unit Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.