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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)

Neuroendocrine Tumors Clinical Trial

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

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05268952
Study type Interventional
Source University Hospital, Antwerp
Contact Timon Vandamme
Phone 038212111
Email timon.vandamme@uza.be
Status Recruiting
Phase N/A
Start date May 27, 2019
Completion date December 31, 2025
View Details
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