Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Completed

• Conditions: Neuroendocrine Tumors; Pancreatic Neuroendocrine Tumors

• Registration Number: 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).

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.	3 years

Secondary Outcome Measures

Name	Time	Method
To correlate genomic findings with treatment and clinical outcome.	3 years
To evaluate gene alterations differences between carcinoid tumors and islet cell tumors.	3 years
To bank remaining samples for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).	3 years
To compare acquired data with existent available databases of whole genome or exome of neuroendocrine tumors	3 years

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada