Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-07 @ 9:13 PM
Study NCT ID:
NCT02270567
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-13
First Post:
2014-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RegisterNET - A Registry for Neuroendocrine Tumors in the USA and Worldwide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood collection (RNA stabilization tube) used for neuroendocrine tumor biomarker measurements (NETest)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor-related recurrence or progression', 'timeFrame': '5 years', 'description': 'Image-based identification of recurrent or progressive tumor disease'}, {'measure': 'Tumor-related diagnosis', 'timeFrame': '1 year', 'description': 'Histological confirmation of neuroendocrine tumor'}, {'measure': 'Tumor-related mortality', 'timeFrame': '10 years', 'description': 'Survival from disease'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Evaluation', 'timeFrame': '5 years', 'description': 'Questionnaire to evaluate quality of life status'}, {'measure': 'Biomarker prediction of treatment response and disease relapse', 'timeFrame': '10 years', 'description': 'Biomarker prediction of treatment response and disease relapse. This involves measurements of changes in NETest levels between two time-points. Changes can be in actual values or be evaluated as % change. Alterations in blood measurements can be correlated with survival curves (PFS and/or OS).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PRRT', 'Somatostatin Analogue', 'NETest', 'Progression', 'PPQ'], 'conditions': ['Neuroendocrine Tumor', 'Carcinoid', 'Neuroendocrine Carcinoma']}, 'referencesModule': {'references': [{'pmid': '23691035', 'type': 'BACKGROUND', 'citation': 'Modlin IM, Drozdov I, Kidd M. The identification of gut neuroendocrine tumor disease by multiple synchronous transcript analysis in blood. PLoS One. 2013 May 15;8(5):e63364. doi: 10.1371/journal.pone.0063364. Print 2013.'}, {'pmid': '24127543', 'type': 'BACKGROUND', 'citation': 'Modlin IM, Drozdov I, Kidd M. Gut neuroendocrine tumor blood qPCR fingerprint assay: characteristics and reproducibility. Clin Chem Lab Med. 2014 Mar;52(3):419-29. doi: 10.1515/cclm-2013-0496.'}, {'pmid': '25015994', 'type': 'BACKGROUND', 'citation': 'Modlin IM, Drozdov I, Alaimo D, Callahan S, Teixiera N, Bodei L, Kidd M. A multianalyte PCR blood test outperforms single analyte ELISAs (chromogranin A, pancreastatin, neurokinin A) for neuroendocrine tumor detection. Endocr Relat Cancer. 2014 Aug;21(4):615-28. doi: 10.1530/ERC-14-0190.'}, {'pmid': '25095873', 'type': 'BACKGROUND', 'citation': 'Modlin IM, Drozdov I, Bodei L, Kidd M. Blood transcript analysis and metastatic recurrent small bowel carcinoid management. BMC Cancer. 2014 Aug 5;14:564. doi: 10.1186/1471-2407-14-564.'}, {'pmid': '39945192', 'type': 'RESULT', 'citation': 'Kidd M, Drozdov IA, Chirindel A, Nicolas G, Imagawa D, Gulati A, Tsuchikawa T, Prasad V, Halim AB, Strosberg J. NETest(R) 2.0-A decade of innovation in neuroendocrine tumor diagnostics. J Neuroendocrinol. 2025 Apr;37(4):e70002. doi: 10.1111/jne.70002. Epub 2025 Feb 13.'}, {'pmid': '30158287', 'type': 'RESULT', 'citation': 'Liu E, Paulson S, Gulati A, Freudman J, Grosh W, Kafer S, Wickremesinghe PC, Salem RR, Bodei L. Assessment of NETest Clinical Utility in a U.S. Registry-Based Study. Oncologist. 2019 Jun;24(6):783-790. doi: 10.1634/theoncologist.2017-0623. Epub 2018 Aug 29.'}, {'pmid': '32392558', 'type': 'DERIVED', 'citation': 'Kidd M, Kitz A, Drozdov I, Modlin I. Neuroendocrine Tumor Omic Gene Cluster Analysis Amplifies the Prognostic Accuracy of the NETest. Neuroendocrinology. 2021;111(5):490-504. doi: 10.1159/000508573. Epub 2020 May 11.'}]}, 'descriptionModule': {'briefSummary': 'Neuroendocrine tumors are derived from the neuroendocrine system of the gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery, medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at collecting data and blood samples from patients presenting with a NET. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry through prospective agreements and sub-study protocols with Wren Laboratories. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.', 'detailedDescription': 'Background: Survival for neuroendocrine tumors is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. Non-invasive biomarkers have been identified that can improve diagnosis and prognosis of patients. Little, however, is known about the utility of these markers in clinical practice.\n\nObjective: To systematically and prospectively collect clinical information and blood samples for NETest from neuroendocrine tumors to evaluate the clinical validity of this biomarker for diagnosis, surveillance, and prediction of disease prognosis and response to targeted therapeutics.\n\nMethods: All neuroendocrine tumors (gastroenteropancreatic and pulmonary) are following informed consent. Data will be entered prospectively and anonymized. Patient history including a quality of life survey are completed by contributing physicians and blood sample is collected for analysis. All information will be transferred to the database. Evaluation of treatment modalities and patient outcomes (e.g. disease recurrence) will be assessed at follow-up times.\n\nThe primary objectives of the project are to:\n\n* monitor patients with neuroendocrine tumors\n* provide descriptive statistical analyses\n* assessment of diagnostic accuracy of NETest\n\nThe secondary objectives of the project include:\n\n* assessment of disease recurrence, progression and prognosis\n* analysis of patient survival\n\nAnalyses will include:\n\n1. Descriptive statistical analyses including demographics, site, treatment, QoL assessment.\n2. Clinical follow-up and blood chemistry results.\n3. Correlation analyses between blood results e.g., changes in NETest and clinical data. This will include assessment of the time at which the blood chemistry results significantly (and consistently) increases and the time of tumor recurrence and an evaluation whether the change in blood results is predictive of disease recurrence or progression. Changes can also be used for prognosis and evaluating response to therapies e.g., PRRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a histologically confirmed diagnosis of a neuroendocrine tumor undergoing treatment and follow-up evaluation. This includes real-world patients as well as patients included in investigator-initiated clinical studies (IICS) e.g., PRRT or curative surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastroenteropancreatic neuroendocrine tumor\n* Bronchopulmonary neuroendocrine tumor\n* Gastroenteropancreatic neuroendocrine carcinoma\n* Pre- and post-surgical patients\n* Watch \\& Wait/no treatment\n* Treatment including somatostatin analogues, PRRT, targeted therapies.\n* Patient provides informed consent\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT02270567', 'acronym': 'RegisterNET', 'briefTitle': 'RegisterNET - A Registry for Neuroendocrine Tumors in the USA and Worldwide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wren Laboratories LLC'}, 'officialTitle': 'A Registry for Neuroendocrine Tumors', 'orgStudyIdInfo': {'id': 'WREN_REGISTER_01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NETest', 'type': 'DEVICE', 'otherNames': ['Multianalyte Algorithm Analysis of circulating neuroendocrine tumor transcripts'], 'description': 'Non-invasive blood test'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06405', 'city': 'Branford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Wren Laboratories', 'geoPoint': {'lat': 41.27954, 'lon': -72.8151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identififed, anonymized information including changes in NETest and outcomes e.g., PFS.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wren Laboratories LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}