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Surgical Intervention and the NETest (NETest_Sx)

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ClinicalTrials.gov Identifier: NCT03012789
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Wren Laboratories LLC

Brief Summary:
The purpose of this study is to evaluate the effect of different surgical resections (R0, R1, R2) on circulating NET transcripts (PCR score or NETest). A drop in circulating NET levels will be correlated with surgical excision. Secondly, variation of circulating NET transcripts will be correlated to NET recurrence to test whether this analysis may constitute an early predictive marker of disease relapse.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Gastroenteropancreatic Procedure: Surgery Not Applicable

Detailed Description:
Biomarker-based tools that can accurately predict gastroenteropancreatic neuroendocrine tumor (GEP-NET) treatment response and tumor recurrence are currently not available. Circulating biomarkers that are associated with GEP-NETs are limited to measurements of plasma chromogranin A (CgA). The investigators have developed a PCR-based tool to quantitate (score) the circulating GEP-NET molecular signature ("liquid" biopsy) with high sensitivity and specificity. This signature can identify all types of GEP-NETs including small (1cm) non-metastatic tumors, is significantly reduced after tumor debulking and is decreased following surgical "cure". Elevated post-surgical scores are associated with tumor recurrence within 6 months in ~40% of cases. Current NET treatment protocols are associated with tumor recurrence (progression free survival) ranging from 5-18 months. The majority of patients will experience a relapse within 18 months irrespective of the treatment approach. The investigators hypothesize that a PCR measurement of circulating NET mRNA can accurately predict the extent of surgical resection (tumor removal) and elevated scores can predict tumor relapse before this occurs. This biomarker protocol seeks to test this hypothesis and evaluate whether changes in plasma CgA are as effective in predicting resection and recurrence.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diagnosis of Neuroendocrine Neoplasms and Assessment of Response to Surgery by Means of Measurement of Gene Transcripts in Blood
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Post Surgery Procedure: Surgery
Surgical excision




Primary Outcome Measures :
  1. Biomarker prediction of tumor recurrence [ Time Frame: 24 months ]
    Analysis of the alterations in the biomarker levels (from post-surgical levels, i.e., month 1) will be utilized to establish when the disease status has altered; a sustained increase in score will be recorded and compared with imaging to assess whether this is associated with disease progression/recurrence.


Secondary Outcome Measures :
  1. Biomarkers and clinical symptomatology [ Time Frame: 24 months ]
    Biomarker scores will be compared to the frequency of clinical symptoms, specifically flushing, to assess whether there is a relationship.

  2. Biomarkers and clinical symptomatology [ Time Frame: 24 months ]
    Biomarker scores will be compared to the frequency of clinical symptoms, specifically diarrhea, to assess whether there is a relationship.


Other Outcome Measures:
  1. Alteration in biomarkers and tumor removal [ Time Frame: 24 months ]
    Analysis of the change in biomarker scores (from baseline to post-surgical levels at 1 month) will be utilized to establish the strength of the relationship between the biomarker and volume of tumor removed (cm3).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed, well differentiated (G1, G2 or G3), local and advanced (metastatic), neuroendocrine tumor of gastro-enteropancreatic origin.
  • Treatment-naïve as well as patients who have received previous therapies.
  • Patients currently on LAR with clinically stable disease.
  • CT or MRI documentation of disease.
  • WHO performance status ≤2.

Exclusion Criteria:

  • Known history of HIV seropositivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012789


Locations
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Italy
San Raffaele Hospital IRCCS Recruiting
Milano, Italy, 20132
Contact: Massimo Falconi, MD, PhD    39 0226436046    folli.maura@hsr.it   
Contact: Stefano Partelli, MD    39 3497733237    partelli.stefano@hsr.it   
Sponsors and Collaborators
Wren Laboratories LLC

Publications of Results:
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Responsible Party: Wren Laboratories LLC
ClinicalTrials.gov Identifier: NCT03012789     History of Changes
Other Study ID Numbers: Surgery_NETest
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue