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Neuroendocrine TumorsNETNCT05168631

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

An observational study of Neuroendocrine Tumors and Carcinoma;Endocrine, run by Latin American Cooperative Oncology Group at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors, Carcinoma;Endocrine
How many people
88 participants
Where
8 sitesin 4 countries
Study dates
16 May 2020to 28 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 18 years or older and with histologically confirmed neuroendocrine tumors; or metastatic or inoperable disease; or patients with clinical information about the therapies received, including exclusive palliative care.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Brazil4 sites

  • Universidade Federal do Ceará/HOSPITAL UNIVERSITARIO WALTER CANTIDIO

    Fortaleza, Ceará

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul

  • Ensino E Terapia de Inovacao Clinica Amo - Etica

    Salvador, Estado de Bahia

  • Fundacao Antonio Prudente - Ac Camargo Center

    São Paulo, São Paulo

Other trials in Brazil

Argentina2 sites

  • Hospital de Gastroenterología Carlos Bonorino Udaondo

    Buenos Aires, Buenos Aires

  • Instituto Alexander Fleming

    Buenos Aires, Buenos Aires

Other trials in Argentina

Mexico1 site

  • INCan - Instituto Nacional de Cancerología

    Mexico City, Mexico City

Other trials in Mexico

Peru1 site

  • Instituto Nacional de Enfermedades Neoplàsicas

    Surquillo

Other trials in Peru

About this study

Multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors.

Medical subject headings
Neuroendocrine Tumors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 2022

Secondary outcomes (4)

  1. Response rate per RECIST 1.1;

    Measured: 2022

  2. Progression-free survival by RECIST 1.1 from D1 of each treatment;

    Measured: 2022

  3. Symptom control time

    Improvement of symptoms and/or stabilization of radiological disease in non-functioning ENT, at the physician's discretion

    Measured: 2022

  4. Incidence of complications of the disease and/or treatments, defined by adverse events

    Measured: 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start16 May 2020
  3. Primary completion28 Jun 2022
  4. Study completion28 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168631
Sponsor's protocol ID
LACOG 0119
Acronym
NET
Status last verified
Aug 2026
First submitted
20 Dec 2021
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18565894

  • 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.

    PubMed 25312765

  • 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.

    PubMed 28448665

  • 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.

    PubMed 27759713

  • 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.

    PubMed 25723112

  • 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.

    PubMed 28955403

  • 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.

    PubMed 26482044

  • 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.

    PubMed 28018101

  • 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.

    PubMed 28456055

  • 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.

    PubMed 27259015

  • 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.

    PubMed 29629316

  • 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.

    PubMed 27594907

  • 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.

    PubMed 28194228

  • 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.

    PubMed 19097774

  • 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.

    PubMed 7165009

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine Tumors and Carcinoma;Endocrine, run by Latin American Cooperative Oncology Group at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil, Argentina, Mexico, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168631, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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