Surgical Intervention and the NETest

NCT03012789 | Active Not Recruiting

• 1 other identifier: Surgery_NETest
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumor; Gastroenteropancreatic

Outcome Measures

Primary Outcomes (1)

• Biomarker prediction of tumor recurrence

  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.

  24 months

Secondary Outcomes (2)

• Biomarkers and clinical symptomatology

  24 months

• Biomarkers and clinical symptomatology

  24 months

Other Outcomes (1)

• Alteration in biomarkers and tumor removal

  24 months

Study Arms (1)

Post Surgery

OTHER

Procedure: Surgery

Interventions

Surgery PROCEDURE

Surgical excision

Post Surgery

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Known history of HIV seropositivity

Sponsors & Collaborators

• Wren Laboratories LLC: lead

Study Sites (1)

San Raffaele Hospital IRCCS

Milan, 20132, Italy

Location

Related Publications (3)

• Modlin IM, Frilling A, Salem RR, Alaimo D, Drymousis P, Wasan HS, Callahan S, Faiz O, Weng L, Teixeira N, Bodei L, Drozdov I, Kidd M. Blood measurement of neuroendocrine gene transcripts defines the effectiveness of operative resection and ablation strategies. Surgery. 2016 Jan;159(1):336-47. doi: 10.1016/j.surg.2015.06.056. Epub 2015 Oct 9.

  PMID: 26456125 RESULT

• Modlin IM, Kidd M, Bodei L, Drozdov I, Aslanian H. The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. Am J Gastroenterol. 2015 Aug;110(8):1223-32. doi: 10.1038/ajg.2015.160. Epub 2015 Jun 2.

  PMID: 26032155 RESULT

• Oberg K, Modlin IM, De Herder W, Pavel M, Klimstra D, Frilling A, Metz DC, Heaney A, Kwekkeboom D, Strosberg J, Meyer T, Moss SF, Washington K, Wolin E, Liu E, Goldenring J. Consensus on biomarkers for neuroendocrine tumour disease. Lancet Oncol. 2015 Sep;16(9):e435-e446. doi: 10.1016/S1470-2045(15)00186-2.

  PMID: 26370353 RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 6, 2017
• Study Start: May 15, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

IT (1)