Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors (NET-SEQ)

University Health Network, Toronto

Status: Completed

Conditions: Pancreatic Neuroendocrine Tumors; Neuroendocrine Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT02586844

NET-SEQ

Details and patient eligibility

About

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.

Full 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: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

13 participants in 2 patient groups

Neuroendocrine tumors (NETs)

Description:

Eligible consenting patients will undergo one-time biopsy, during which at least 3 tumors' core samples (total length of at least 6 cm) will be collected. Core tumor biopsies and 3 vials of whole blood and archived tumor specimens will be obtained for genomic testing analysis.

panNETs

Description:

Eligible consenting patients will undergo one-time biopsy, during which at least 3 tumors' core samples (total length of at least 6 cm) will be collected. Core tumor biopsies and 3 vials of whole blood and archived tumor specimens will be obtained for genomic testing analysis.