Multicenter Retrospective Database on Prognostic and Predictive Factors in Patients With Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

Multicenter Retrospective Database on Prognostic and Predictive Factors in Patients With Neuroendocrine Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05168631
• Other study ID #: LACOG 0119
• Status: Active, not recruiting
• Start date: May 16, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: July 1, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older and with histologically confirmed neuroendocrine tumors;
• Metastatic or inoperable disease;
• Patients with clinical information about the therapies received, including exclusive palliative care.

Exclusion Criteria:

• Lack of data on survival outcomes and/or details on treatments received.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Locations

Country	Name	City	State
Brazil	Hospital Sírio Libanês Brasília	Brasília	Distrito Federal
Brazil	Universidade Federal do Ceará/HOSPITAL UNIVERSITARIO WALTER CANTIDIO	Fortaleza	Ceará
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Ensino E Terapia de Inovacao Clinica Amo - Etica	Salvador	Bahia
Brazil	Fundacao Antonio Prudente - Ac Camargo Center	São Paulo
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo
Peru	Instituto Nacional de Enfermedades Neoplàsicas	Surquillo

Sponsors (1)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group

Countries where clinical trial is conducted

Brazil,  Peru, 

References & Publications (15)

Basturk O, Yang Z, Tang LH, Hruban RH, Adsay V, McCall CM, Krasinskas AM, Jang KT, Frankel WL, Balci S, Sigel C, Klimstra DS. The high-grade (WHO G3) pancreatic neuroendocrine tumor category is morphologically and biologically heterogenous and includes both well differentiated and poorly differentiated neoplasms. Am J Surg Pathol. 2015 May;39(5):683-90. doi: 10.1097/PAS.0000000000000408. — View Citation

Crippa S, Partelli S, Belfiori G, Palucci M, Muffatti F, Adamenko O, Cardinali L, Doglioni C, Zamboni G, Falconi M. Management of neuroendocrine carcinomas of the pancreas (WHO G3): A tailored approach between proliferation and morphology. World J Gastroenterol. 2016 Dec 7;22(45):9944-9953. doi: 10.3748/wjg.v22.i45.9944. — View Citation

Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. — View Citation

de M Rego JF, de Medeiros RSS, Braghiroli MI, Galvao B, Neto JEB, Munhoz RR, Guerra J, Nonogaki S, Kimura L, Pfiffer TE, de Castro G Jr, Hoff PM, Filho DR, Costa FP, Riechelmann RP. Expression of ERCC1, Bcl-2, Lin28a, and Ki-67 as biomarkers of response to first-line platinum-based chemotherapy in patients with high-grade extrapulmonary neuroendocrine carcinomas or small cell lung cancer. Ecancermedicalscience. 2017 Sep 11;11:767. doi: 10.3332/ecancer.2017.767. eCollection 2017. — View Citation

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. — View Citation

Girardi DM, Silva ACB, Rego JFM, Coudry RA, Riechelmann RP. Unraveling molecular pathways of poorly differentiated neuroendocrine carcinomas of the gastroenteropancreatic system: A systematic review. Cancer Treat Rev. 2017 May;56:28-35. doi: 10.1016/j.ctrv.2017.04.002. Epub 2017 Apr 17. — View Citation

Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015 Feb 15;121(4):589-97. doi: 10.1002/cncr.29099. Epub 2014 Oct 13. — View Citation

Mota JM, Sousa LG, Riechelmann RP. Complications from carcinoid syndrome: review of the current evidence. Ecancermedicalscience. 2016 Aug 8;10:662. doi: 10.3332/ecancer.2016.662. eCollection 2016. — View Citation

Oberg K. Management of functional neuroendocrine tumors of the pancreas. Gland Surg. 2018 Feb;7(1):20-27. doi: 10.21037/gs.2017.10.08. — View Citation

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. — View Citation

Raj N, Valentino E, Capanu M, Tang LH, Basturk O, Untch BR, Allen PJ, Klimstra DS, Reidy-Lagunes D. Treatment Response and Outcomes of Grade 3 Pancreatic Neuroendocrine Neoplasms Based on Morphology: Well Differentiated Versus Poorly Differentiated. Pancreas. 2017 Mar;46(3):296-301. doi: 10.1097/MPA.0000000000000735. — View Citation

Riechelmann RP, Weschenfelder RF, Costa FP, Andrade AC, Osvaldt AB, Quidute AR, Dos Santos A, Hoff AA, Gumz B, Buchpiguel C, Vilhena Pereira BS, Lourenco Junior DM, da Rocha Filho DR, Fonseca EA, Riello Mello EL, Makdissi FF, Waechter FL, Carnevale FC, Coura-Filho GB, de Paulo GA, Girotto GC, Neto JE, Glasberg J, Casali-da-Rocha JC, Rego JF, de Meirelles LR, Hajjar L, Menezes M, Bronstein MD, Sapienza MT, Fragoso MC, Pereira MA, Barros M, Forones NM, do Amaral PC, de Medeiros RS, Araujo RL, Bezerra RO, Peixoto RD, Aguiar S Jr, Ribeiro U Jr, Pfiffer T, Hoff PM, Coutinho AK. Guidelines for the management of neuroendocrine tumours by the Brazilian gastrointestinal tumour group. Ecancermedicalscience. 2017 Jan 26;11:716. doi: 10.3332/ecancer.2017.716. eCollection 2017. — View Citation

Tang LH, Basturk O, Sue JJ, Klimstra DS. A Practical Approach to the Classification of WHO Grade 3 (G3) Well-differentiated Neuroendocrine Tumor (WD-NET) and Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) of the Pancreas. Am J Surg Pathol. 2016 Sep;40(9):1192-202. doi: 10.1097/PAS.0000000000000662. — View Citation

Tang LH, Untch BR, Reidy DL, O'Reilly E, Dhall D, Jih L, Basturk O, Allen PJ, Klimstra DS. Well-Differentiated Neuroendocrine Tumors with a Morphologically Apparent High-Grade Component: A Pathway Distinct from Poorly Differentiated Neuroendocrine Carcinomas. Clin Cancer Res. 2016 Feb 15;22(4):1011-7. doi: 10.1158/1078-0432.CCR-15-0548. Epub 2015 Oct 19. Erratum In: Clin Cancer Res. 2016 Aug 15;22(16):4273. — View Citation

Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2022
Secondary	Response rate per RECIST 1.1;		2022
Secondary	Progression-free survival by RECIST 1.1 from D1 of each treatment;		2022
Secondary	Symptom control time	Improvement of symptoms and/or stabilization of radiological disease in non-functioning ENT, at the physician's discretion	2022
Secondary	Incidence of complications of the disease and/or treatments, defined by adverse events		2022