Official Title
Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Brief Title
Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Protocol ID
NCT02586844
Lead Sponsor
University Health Network, Toronto
Brief Summary
Prospective study to obtain fresh tumor biopsies and three blood samples from patients
with a confirmed histological or cytological diagnosis of well-differentiated
neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors
(PanNETs) for molecular profiling.
Detailed Description
In this prospective study the aim is to obtain fresh tumor biopsies and three blood
samples from patients with a confirmed histological or cytological diagnosis of
well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic
neuroendocrine tumors (PanNETs). Eligible population includes: NETs and PanNETs patients
who have undergone or are undergoing treatment with targeted therapies and have shown
prolonged clinical benefit, and NETs and PanNETs patients who have been treated with
these agents and just recently progressed. RNA and DNA from fresh tumor biopsies and from
mononuclear blood cells will be subjected to transcriptome sequencing and DNA sequencing
analyses to evaluate possible genes of interest and related targetable pathways.
Moreover, archived tumor samples will be requested from all patients to perform
additional genomic testing. Remaining RNA and DNA will be banked for additional
exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or
epigenetic evaluations).
Enrollment Count
13 participants
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years.
- Histological or cytological proof of NETs or PanNETs.
- At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- Current/recent treatment with targeted therapies with confirmed clinical benefit;
confirmed progression disease to targeted therapies at the time of study enrollment.
- Fulfills local institution's laboratory parameters for tumor biopsy.
- Willingness and ability of patient to provide signed voluntary informed consent.
Exclusion Criteria:
- Any condition that could interfere with their ability to provide informed consent
such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy or blood collection procedure.
Filters
Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors
COMPLETED
ADULT
OLDER_ADULT