Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms (NEN) Patients - Collection of NET (CollectNET) 2.0, a Study by the BE-FORCE Consortium (BE-FORCE)

August 1, 2024 updated by: University Hospital, Antwerp

Collection of Liquid Biopsy Samples of Patients With Neuroendocrine Neoplasms - CollectNET 2.0, a Study by the BE-FORCE Consortium

The CollectNET 2.0 by BE-FORCE is a prospective, multicentric, interventional study in which liquid biopsies will be collected from neuroendocrine neoplasms (NEN) patients to create an extensive biobank that will be used for current and future circulating cell-free DNA (ccfDNA) analyses. Two sampling groups will be created: the "Regular Sampling Group" and the "Intensive Sampling Group". Upon participation, up to four additional blood tubes (max. total of 32.5mL) will be collected at each timepoint as specified below. These include 3 Streck Cell-Free DNA tubes (10 mL each) which will be used for the extraction of ccfDNA and 1 PreAnalytiX (PAXgene)® Blood RNA tube (2.5 mL). All NEN patients in one of the participating hospitals who have measurable tumor burden on imaging will be asked to participate in our study and will be included in the "Regular Sampling Group". If additionally, the patient is (i) diagnosed with a histologically confirmed NEN of World Health Organisation (WHO) 2019 grade 1-3 neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC) from pancreatic, colorectal or small intestinal origin and (ii) is starting any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.), they will be followed up more intensively as per the "Intensive Sampling Group". If during follow-up in this "Intensive Sampling Group" patients have disease progression or have completed follow-up for 3 years in this group, their follow-up will switch back to the "Regular Sampling Group" for the remainder of the study. Ultimately, the samples collected in the "Intensive Sampling Group" will be used to achieve the second and third objective of our current project. These are to validate novel ccfDNA analyzing techniques (IMPRESS and GIPXplore) for assessment of the presence and quantification of circular tumor DNA (ctDNA) in liquid biopsies, and to monitor tumor fraction (i.e., ctDNA quantities) over time in sequential plasma samples from NEN patients using ccfDNA assays and correlating this with time to progression (according to RECIST 1.1 criteria) to explore the predictive efficacy of ccfDNA analysis and thereby evaluate its biomarker potential for patient follow-up. While samples from the "Regular Sampling Group" and the PAXgene tubes will be biobanked for future projects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Not yet recruiting
        • AZ Monica
        • Contact:
        • Principal Investigator:
          • Luc Poelmans
      • Antwerpen, Belgium, 2020
      • Antwerpen, Belgium, 2610
        • Not yet recruiting
        • Gasthuiszusters Ziekenhuizen (GZA)
        • Principal Investigator:
          • Isabelle Maurissen, Dr
        • Contact:
      • Brasschaat, Belgium, 2930
        • Not yet recruiting
        • AZ Klina
        • Contact:
        • Principal Investigator:
          • Wim Demey
      • Edegem, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital (UZA)
        • Contact:
        • Principal Investigator:
          • Timon Vandamme
    • Antwerp
      • Rumst, Antwerp, Belgium
        • Not yet recruiting
        • AZ Rivierenland
        • Contact:
        • Principal Investigator:
          • Marijke Ulenaers
    • East-Flanders
      • Sint-Niklaas, East-Flanders, Belgium
        • Not yet recruiting
        • Vitaz
        • Principal Investigator:
          • Willem Lybaert
        • Contact:
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium
        • Not yet recruiting
        • University Hospital Leuven
        • Contact:
          • Kristien Dumon
        • Principal Investigator:
          • Chris Verslype

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

NEN patients

Description

Inclusion Criteria:

  • Male or female ≥ 18 years of age on the day of signing informed consent.
  • Written informed consent must be obtained from the patient or patient's legal representative.
  • Patient is willing and able (in the investigator's opinion) to comply with all trial requirements.
  • For inclusion in the Regular Sampling Group: patients must have (had) a histologically confirmed NEN diagnosis, patients must have measurable tumor burden on imaging, patients must be in follow-up in one of the participating hospitals and patients who have progressed or completed follow-up for 3y in the Intensive Sampling Group.
  • For inclusion in the Intensive Sampling Group: patients who are included in the Regular Sampling Group and where either a baseline sample (RSG-B) or a recent RSG follow-up sample (RSG-V…) has been collected before the start of 1st systemic treatment (as defined below), patients must be diagnosed with a histologically confirmed NEN diagnosis of a WHO 2019 grade 1-3 NET or NEC of pancreatic, colorectal, or small intestinal origin and patients must start any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.).

Exclusion Criteria:

  • Patients who are unable to give informed consent.
  • Patients for which blood sampling would compromise their overall health.
  • Patients pregnant at time of study entry or are willing to become pregnant during the study.
  • Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Regular Sampling Group (RSG)
This group consists of all NEN patients who have measurable tumor burden on imaging (and who do not fulfill the criteria for the Intensive Sampling Group) and are willing to participate in the study.
Diagnostic test: Shallow Whole Genome Sequencing (sWGS)-GIPXplore
GIPXplore will be used to mine shallow whole genome sequencing cell free DNA data for identification of signatures.
Diagnostic test: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay
Aberrant methylation in ccfDNA will be analyzed using the novel, highly sensitive MSRE-smMIP-seq technology.
Intensive Sampling Group (ISG)
This group consists of patients who at baseline or during the course of the study patients in this group (i) have a histologically confirmed NEN of WHO 2019 grade 1-3 NET or NEC from pancreatic, colorectal, or small intestinal origin and (ii) are starting any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.).
Diagnostic test: Shallow Whole Genome Sequencing (sWGS)-GIPXplore
GIPXplore will be used to mine shallow whole genome sequencing cell free DNA data for identification of signatures.
Diagnostic test: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay
Aberrant methylation in ccfDNA will be analyzed using the novel, highly sensitive MSRE-smMIP-seq technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validating novel ccfDNA analyzing techniques for assessment of the presence and quantification of ctDNA in liquid biopsies derived from NEN patients
Time Frame: 5 years after informed consent form (ICF) signature
ctDNA fraction
5 years after informed consent form (ICF) signature
Monitoring tumor fraction over time in sequential plasma samples from NEN patients using ccfDNA assays
Time Frame: 5 years after ICF signature
ctDNA quantities
5 years after ICF signature
Correlate tumor fraction with time to progression (according to RECIST 1.1 criteria)
Time Frame: 5 years after ICF signature
tumor fraction
5 years after ICF signature

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universitaire Ziekenhuizen KU Leuven
KU Leuven
Universiteit Antwerpen

Investigators

  • Principal Investigator: Timon Vandamme, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Estimated)

December 4, 2028

Study Completion (Estimated)

December 4, 2030

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3002021000275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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