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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586844
Other study ID # NET-SEQ
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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