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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Blood sampling will be done at regular intervals
Scans will be done at regular intervals
GZA
Antwerp, Antwerp, Belgium
AZ Rivierenland
Bornem, Antwerp, Belgium
AZ Klina
Brasschaat, Antwerp, Belgium
AZ Monica
Deurne, Antwerp, Belgium
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)).
Time frame: 48 months
PFS under everolimus ± SSA treatment
PFS under everolimus ± SSA treatment
Time frame: 48 months
Overall response rates under everolimus ± SSA treatment
Overall response rates under everolimus ± SSA treatment
Time frame: 48 months
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
Time frame: 48 months
Change in Quality of Life
Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 questionnaire
Time frame: 48 months
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
Time frame: 48 months
Change in Quality of Life
Quality of Life using European Organisation for Research and Treatment of Cancer EuroQol-5 Dimension-3L questionnaire
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Antwerp University Hospital
Edegem, Antwerp, Belgium
AZ Voorkempen
Malle, Antwerp, Belgium
ZNA
Merksem, Antwerp, Belgium
AZ Nikolaas
Sint-Niklaas, East-Flanders, Belgium
Time frame: 48 months
Comparison of PFS based on RECIST 1.1 and PERCIST 1.0
Comparison of PFS based on RECIST 1.1 and PERCIST 1.0
Time frame: 48 months