AzTrials
AzTrials

Neuroendocrine TumorsLiquid-NETNCT05255133

A Study to Evaluate the Value of Circulating Tumour DNA in Follow-up of Patients With an Advanced Gastroenteropancreatic or Lung Neuroendocrine Tumour Under Everolimus +- SSA Treatment

A study testing Liquid biopsies and Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT) in people with Neuroendocrine Tumors, run by Universiteit Antwerpen at 8 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Prospective, multicentric, single arm, POC study to evaluate the value of CtDNA in follow-up of patients treated with everolimus, with or without somatostatin analogues for advanced gastroenteropancreatic or lung neuroendocrine tumours. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
Liquid biopsies and Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
8 sitesBelgium
Study dates
9 Oct 2017to 23 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Age ≥18 years
  • Written informed consent prior to any study-related procedure
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Histological proven diagnosis of a well or moderately differentiated GEP-NET (WHO2017 grade 1,2,3 neuroendocrine tumour)
  • Documented progressive gastroenteropancreatic or lung neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria and/or PERCIST 1.0 criteria (if available) for which the treating physician has decided to treat with everolimus ± SSA treatment
  • Presenting a positive CT and/or DOTANOC scan (at physician's discretion) at study entry with a measurable tumour lesion > 1 cm (CT scan with a maximum slice thickness of 5 mm); baseline CT and/or DOTANOC scan performed up to 28 days prior start of treatment
Show all 21Show fewer
  • NO previous treatment with everolimus
  • Adequate bone marrow and coagulation function as shown by:
  • Haemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm3 (≥1.5 x 109/L)
  • Platelets ≥ 100,000/mm3 (≥ 100x 109/L)
  • INR ≤ 2.0
  • Adequate liver function as shown by:
  • Alanine aminotransferase and aspartate aminotransferase ≤2.5xULN (Upper limit of normal) (or ≤ 5 if hepatic metastases are present)
  • Total serum bilirubin ≤ 1.5 x ULN (≤ 3 ULN for patients known to have Gilbert Syndrome)
  • Adequate renal function as shown by Serum creatinine≤ 1.5 x ULN
  • Fasting serum cholesterol, triglycerides and glucose
  • Fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L
  • Fasting triglycerides ≤ 2.5 x ULN
  • Fasting glucose < 1.5 x ULN
  • Availability of FFPE tissue of GEP-NET or lung NET tumour tissue or patient willing to have a new biopsy in case of non-availability of tissue

Who cannot join

  • Patients with only non-measurable lesions by CT
  • Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) or other contra-indications for everolimus ± SSA treatment
  • Unavailable archival tissue and patient unwilling to have a new biopsy
  • Prior treatment with everolimus
  • History of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg, sandostatin LAR or everolimus
  • Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy
Show all 35Show fewer
  • History or clinical evidence of other malignancy within 3 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
  • Major surgery within 4 weeks of first dose administration
  • History of symptomatic brain metastases or other central nervous system metastases.
  • Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use at the time of study entry except in cases outlined below:
  • Topical applications (e.g. rash)
  • Inhaled sprays (e.g. obstructive airways disease)
  • Eye drops
  • Local injections (e.g. intra-articular)
  • Stable low dose of corticosteroids for at least two weeks before enrolment
  • Patients with known HIV seropositivity. Screening for HIV infection at baseline is not required
  • Acute and chronic, active infectious disorders (including hepatitis patients)
  • Chronic pulmonary medical conditions or acute respiratory problems
  • Active bleeding diathesis
  • On oral anti-vitamin K medication with an INR ≥3
  • Any severe uncontrolled medical condition such as:
  • Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to enrolment, uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes defined as fasting glycemia > 150 mg/dl.
  • Acute and chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy.
  • Symptomatic deterioration of lung function
  • Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazoleonazole, Voriconazole, Ritonavir, Telithromycin) within the last 5 days prior to enrolment
  • Patients that will likely require treatment during the study with drugs that are not permitted by the study protocol.
  • History of non-compliance to medical regimens
  • Concurrent anti-cancer treatment in another investigational trial, other than the everolimus ± SSA treatment
  • Patients that are likely to require any additional concomitant treatment with anti-proliferative effect for the pancreatic neuroendocrine tumour
  • Patients unwilling or unable to comply with the protocol or patients with mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
  • Any abnormal findings at baseline, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
  • Childbearing potential (unless using an adequate measure of contraception)
  • Pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non-childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study.
  • Has previously been enrolled in this study

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Belgium8 sites

  • GZA

    Antwerp, Antwerp, 2610

  • AZ Rivierenland

    Bornem, Antwerp, 2880

  • AZ Klina

    Brasschaat, Antwerp, 2930

  • AZ Monica

    Deurne, Antwerp, 2100

  • Antwerp University Hospital

    Edegem, Antwerp, 2650

  • AZ Voorkempen

    Malle, Antwerp, 2390

  • ZNA

    Merksem, Antwerp, 2170

  • AZ Nikolaas

    Sint-Niklaas, East-Flanders, 9100

Other trials in Belgium

About this study

Official title: A Prospective, Multicentric, Proof-of-concept Study to Evaluate the Value of Circulating Tumour DNA in Follow-up of Patients With an Advanced Gastroenteropancreatic or Lung Neuroendocrine Tumour Under Everolimus +- SSA Treatment

Prospective, multicentric, single arm, POC study to evaluate the value of CtDNA in follow-up of patients treated with everolimus, with or without somatostatin analogues for advanced gastroenteropancreatic or lung neuroendocrine tumours.

Read the detailed description

Prospective, multicentric, single arm, POC study to evaluate the value of CtDNA in follow-up of patients treated with everolimus, with or without somatostatin analogues for advanced gastroenteropancreatic or lung neuroendocrine tumours. Inclusion is possible after proven progressive disease on CT and/or DOTANOC scan (at physician's discretion) and decision of physician to start everolimus ± SSA treatment. During the study, CT and/or DOTANOC scans (thorax/abdomen/pelvis) (at physician's discretion) will be performed to detect progressive disease and CtDNA levels will be measured from the start of the treatment. The changes in CtDNA levels will be correlated to the tumour disease progression based on imaging (RECIST 1.1 and or PERCIST 1.0 (if available)) and laboratory and clinical markers. Characterization of CtDNA will be based on detection of tumour-specific alterations (i.e. mutations, copy number alterations and DNA methylation) using next-generation sequencing, digital droplet PCR and a photoelectrochemical biosensor. The identification of tumour-specific mutations will be done using next-generation sequencing of tumour tissue.

Being tested
Liquid biopsies, Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT)
Keywords
Liquid biopsies
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liquid biopsiesOther

    Blood sampling will be done at regular intervals

  • Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT)Other

    Scans will be done at regular intervals

Study groups in NCT05255133
Study groupRoleWhat they receive
GEP-NET and lung-NET patientsExperimentalLiquid biopsies and scans
Receives: Other: Liquid biopsies; Other: Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of treatment follow-up through CtDNA level measurement

    Feasibility of treatment follow-up through detection of a change in CtDNA levels before progression is apparent on imaging according to RECIST 1.1 and/or PERCIST 1.0 (if available) (Progression-free survival (PFS)).

    Measured: 48 months

Secondary outcomes (7)

  1. PFS under everolimus ± SSA treatment

    PFS under everolimus ± SSA treatment

    Measured: 48 months

  2. Overall response rates under everolimus ± SSA treatment

    Overall response rates under everolimus ± SSA treatment

    Measured: 48 months

  3. Safety of everolimus ± SSA treatment according to the Common Terminology Criteria for Adverse Events 4 (CTCAE4) and in Belgium according to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Number of patients with (serious) adverse events throughout the study

    Measured: 48 months

  4. Change in Quality of Life

    Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 questionnaire

    Measured: 48 months

  5. Change in Quality of Life

    Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Gastrointestinal Neuroendocrine Tumor 21 questionnaire

    Measured: 48 months

  6. Change in Quality of Life

    Quality of Life using European Organisation for Research and Treatment of Cancer EuroQol-5 Dimension-3L questionnaire

    Measured: 48 months

  7. Comparison of PFS based on RECIST 1.1 and PERCIST 1.0

    Comparison of PFS based on RECIST 1.1 and PERCIST 1.0

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start9 Oct 2017
  3. Primary completion23 Jun 2022
  4. Study completion23 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05255133
Sponsor's protocol ID
Liquid-NET
Acronym
Liquid-NET
Status last verified
Jan 2025
First submitted
22 Dec 2021
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boons G, Vandamme T, Marien L, Lybaert W, Roeyen G, Rondou T, Papadimitriou K, Janssens K, Op de Beeck B, Simoens M, Demey W, Dero I, Van Camp G, Peeters M, Op de Beeck K. Longitudinal Copy-Number Alteration Analysis in Plasma Cell-Free DNA of Neuroendocrine Neoplasms is a Novel Specific Biomarker for Diagnosis, Prognosis, and Follow-up. Clin Cancer Res. 2022 Jan 15;28(2):338-349. doi: 10.1158/1078-0432.CCR-21-2291. Epub 2021 Nov 10.

    PubMed 34759042

Questions about this trial

What is this clinical trial studying?

A study testing Liquid biopsies and Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT) in people with Neuroendocrine Tumors, run by Universiteit Antwerpen 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 21 inclusion and 35 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: finished, as of the sponsor's last update on 6 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of treatment follow-up through CtDNA level measurement (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05255133, which also lists 1 linked publication.

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 6 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in