Neuroendocrine NeoplasmsBE-FORCENCT06541080
Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms (NEN) Patients - Collection of NET (CollectNET) 2.0, a Study by the BE-FORCE Consortium
An observational study of Neuroendocrine Neoplasms, run by University Hospital, Antwerp at 8 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Neoplasms
- What is being tested?
- Shallow Whole Genome Sequencing (sWGS)-GIPXplore and methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay
- How many people
- 550 participants
- Where
- 8 sitesBelgium
- Study dates
- 3 Jan 2022to 4 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NEN patients
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Belgium8 sites, 8 recruiting
- Not yet recruiting
Ziekenhuis Netwerk Antwerpen (ZNA)
Antwerp, 2020
Abdelbari Baitar, abdelbari.baitar@zna.be
Myriam Mertens, myriam.mertens@zna.be
- Not yet recruiting
Gasthuiszusters Ziekenhuizen (GZA)
Antwerp, 2610
Caro De Weerdt, caro.deweerdt@uza.be
Isabelle Maurissen, Dr
- Not yet recruiting
AZ Monica
Antwerp
Caro De Weerdt, caro.deweerdt@uza.be
Luc Poelmans
- Not yet recruiting
AZ Klina
Brasschaat, 2930
Sofie Herman, sofie.herman@klina.be
Wim Demey
- Recruiting
Antwerp University Hospital (UZA)
Edegem, 2650
Siddharth Chhajlani, 03436 ext. 8144, siddharth.chhajlani@uantwerpen.be
Timon Vandamme
- Not yet recruiting
University Hospital Leuven
Leuven, Flemish Brabant
Kristien Dumon
Chris Verslype
- Not yet recruiting
AZ Rivierenland
Rumst, Antwerp
Caro De Weerdt, caro.deweerdt@uza.be
Marijke Ulenaers
- Not yet recruiting
VITAZ
Sint-Niklaas, East-Flanders
Caro De Weerdt, caro.deweerdt@uza.be
Willem Lybaert
About this study
Official title: 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.
- Conditions
- Neuroendocrine Neoplasms
- Being tested
- Shallow Whole Genome Sequencing (sWGS)-GIPXplore, methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay
- Keywords
- liquid biopsy, circulating cell-free DNA, methylation-based biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shallow Whole Genome Sequencing (sWGS)-GIPXploreDiagnostic test
GIPXplore will be used to mine shallow whole genome sequencing cell free DNA data for identification of signatures.
methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assayDiagnostic test
Aberrant methylation in ccfDNA will be analyzed using the novel, highly sensitive MSRE-smMIP-seq technology.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Shallow Whole Genome Sequencing (sWGS)-GIPXplore; Diagnostic Test: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay | |
| 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.). Receives: Diagnostic Test: Shallow Whole Genome Sequencing (sWGS)-GIPXplore; Diagnostic Test: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validating novel ccfDNA analyzing techniques for assessment of the presence and quantification of ctDNA in liquid biopsies derived from NEN patients
ctDNA fraction
Measured: 5 years after informed consent form (ICF) signature
Monitoring tumor fraction over time in sequential plasma samples from NEN patients using ccfDNA assays
ctDNA quantities
Measured: 5 years after ICF signature
Correlate tumor fraction with time to progression (according to RECIST 1.1 criteria)
tumor fraction
Measured: 5 years after ICF signature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start3 Jan 2022
- Primary completion4 Dec 2028 (estimated)
- Study completion4 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universiteit Antwerpen, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Timon Vandamme, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541080
- Sponsor's protocol ID
- B3002021000275
- Acronym
- BE-FORCE
- Status last verified
- Dec 2023
- First submitted
- 11 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Liquid Biopsy Samples of Patients With Neuroendocrine Neoplasms - CollectNET 2.0, a Study by the BE-FORCE Consortium
- ClinicalTrials.gov ID
- NCT06541080
- Acronym / sponsor ID
- BE-FORCE / B3002021000275
- Conditions
- Neuroendocrine Neoplasms
- Keywords
- liquid biopsy, circulating cell-free DNA, methylation-based biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universiteit Antwerpen, KU Leuven
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 4 Dec 2028 (estimated)
- Study completion
- 4 Dec 2030 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Sampling Group (RSG) | – | Diagnostic Test: Shallow Whole Genome Sequencing (sWGS)-GIPXplore, Diagnostic Test: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assayThis 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. |
| Intensive Sampling Group (ISG) | – | Diagnostic Test: Shallow Whole Genome Sequencing (sWGS)-GIPXplore, Diagnostic Test: methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assayThis 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.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NEN patients
Key inclusion criteria (5 listed)
- 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.).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shallow Whole Genome Sequencing (sWGS)-GIPXploreGIPXplore will be used to mine shallow whole genome sequencing cell free DNA data for identification of signatures. | Diagnostic test | Intensive Sampling Group (ISG), Regular Sampling Group (RSG) |
| methylation-sensitive restriction enzymes (MSRE)-Single-molecule molecular inversion probes (smMIP)-seq assayAberrant methylation in ccfDNA will be analyzed using the novel, highly sensitive MSRE-smMIP-seq technology. | Diagnostic test | Intensive Sampling Group (ISG), Regular Sampling Group (RSG) |
Primary outcome
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
Monitoring tumor fraction over time in sequential plasma samples from NEN patients using ccfDNA assays
Time frame: 5 years after ICF signature
ctDNA quantities
Correlate tumor fraction with time to progression (according to RECIST 1.1 criteria)
Time frame: 5 years after ICF signature
tumor fraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timon Vandamme principal investigator
University Hospital, Antwerp
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Neoplasms, run by University Hospital, Antwerp at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siddharth Chhajlani (03436 ext. 8144, siddharth.chhajlani@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.