Prospective Comprehensive Molecular Profiling In Neuroend... | NCT02586844

Studies
Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

NCT02586844

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Apr 14, 2022Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Apr 2021Actual

Completion Date

Apr 2021Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Oct 23, 2015

First Posted Date

Oct 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2022

Last Update Posted Date

Apr 14, 2022Actual

Name	Class
Princess Margaret Hospital, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lillian Siu, MD	Princess Margaret Cancer Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Cancer Centre		Toronto	Ontario	M5G2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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