UnknownNot Applicable

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 (Liquid-NET 2.0)

Belgium, Cyprus100 participantsStarted 2019-05-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Haemoglobin ≥ 9.0 g/dL
✓. ANC ≥ 1,500/mm3 (≥1.5 x 109/L)
✓. Platelets ≥ 100,000/mm3 (≥ 100x 109/L)
✓. INR ≤ 2.0
✓. 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)
✓. Fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L
✓. Fasting triglycerides ≤ 2.5 x ULN

Exclusion criteria

✕. 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

What they're measuring

Feasibility of treatment follow-up through CtDNA level measurement

Timeframe: 48 months

Trial details

NCT IDNCT05268952

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-27

Contact for this trial

Timon Vandamme

038212111 timon.vandamme@uza.be

View on ClinicalTrials.gov More Neuroendocrine Tumors trials