Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Study Overview

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.

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).

Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors

NET-SEQ

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-13
First Submitted that Met QC Criteria 2015-10-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-14
First Posted (ACTUAL) 2015-10-26	Results First Posted N/A	Last Verified 2022-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Neuroendocrine tumors (NETs) 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 fo
: panNETs 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 fo

Primary Outcome Measures	Measure Description	Time Frame
To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.		3 years

Secondary Outcome Measures	Measure Description	Time Frame
To evaluate gene alterations differences between carcinoid tumors and islet cell tumors.		3 years
To correlate genomic findings with treatment and clinical outcome.		3 years
To compare acquired data with existent available databases of whole genome or exome of neuroendocrine 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Princess Margaret Hospital, Canada

Investigators

PRINCIPAL_INVESTIGATOR: Lillian Siu, MD, Princess Margaret Cancer Centre

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record