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OpenTrials
Completed

NCT Number: NCT04920955

Relapse Markers for Colorectal Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Digestive Oncology Unit

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  1. Concordance analyses

    Time frame: 24 months

    Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points

  2. Test positivity

    Time frame: 24 months

    Estimation of the multi-marker test positivity for all patients and time points

  3. Coefficient of variation of the biomarkers

    Time frame: 6 weeks

    Intra- and inter-individual coefficient of variation of the biomarkers, pre- and post-surgery and during surveillance up to relapse

  4. Sensitivity for CRC detection

    Time frame: up to 1 day prior to tumor resection

    Sensitivity of the test for detection of primary CRC

Sponsors and collaborators

Lead sponsor

Novigenix SA

Other

Registry information

Official study title

Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse

Acronym: RELMA-C

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 10, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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