Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

NCT02586844 | Completed

• 1 other identifier: NET-SEQ
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors; Pancreatic Neuroendocrine Tumors

Keywords

NET; PanNET; Molecular profiling; Transcriptome sequencing

Outcome Measures

Primary Outcomes (1)

• To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.

  3 years

Secondary Outcomes (4)

• 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

Study Arms (2)

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 for genomic testing analysis.

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 for genomic testing analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histological or cytological diagnosis of NET and PanNET; have at least one biopsiable lesion deemed medically accessible and safe to biopsy; fulfill local institution's laboratory parameters for tumor biopsy, and provided written voluntary informed consent.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue, 3 tubes of whole blood, archival tumor tissue

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Lillian Siu, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2013
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CA (1)