Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

— NET-SEQ  

Official title:

Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586844
• Other study ID #: NET-SEQ
• Status: Completed
• Start date: October 2013
• Est. completion date: April 2021

Study information

• Verified date: April 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumors

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.		3 years
Secondary	To evaluate gene alterations differences between carcinoid tumors and islet cell tumors.		3 years
Secondary	To correlate genomic findings with treatment and clinical outcome.		3 years
Secondary	To compare acquired data with existent available databases of whole genome or exome of neuroendocrine tumors		3 years
Secondary	To bank remaining samples for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).		3 years