NCT04696042Completed
Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs
Prospective Observational Study to Assess the Effectiveness and Safety of Lanreotide Autogel® in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Asia Region
Source: ClinicalTrials.gov · Last updated 28 Jan 2025
Brief summary (registry, in English)
Lanreotide Autogel® has been established as a standard of care for patients with locally advanced or metastatic GEP-NETs based on the success of CLARINET trial. However, only few patients with Asian ethnicity were included in the trial. According to the nationwide comprehensive study of patients with GEP-NET in Korea, hindgut primary NETs(Rectal) occured more frequently than western countries. However, small intestine or lung primary NET is relatively rare compared with western countries.1) Considering the clinical characteristics of GEP-NETs are distinct between the patients in Asian and Western countries, further evaluation on the efficacy and safety of Lanreotide Autogel® in Asian patients with GEP-NETs is needed.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 71 (actual)
- First submitted
- 4 Jan 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- Asan Medical Center
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT04696042
What you commit to
- Study type: Observational
- Participants enrolled: 71
- From 1 Jan 2021 to the primary completion date, 30 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lanreotide treatment for more than 5 months prior inclusion into the study
- Prior anti-proliferative medication with somatostatin analogue (e.g. Octreotide LAR).
- Concomitant anti-proliferative systemic medication/therapies for GEP-NET are not allowed.
Other
- Parallel participation in an interventional study
Who the study is looking for
- Written informed consent
- Male or female subject aged ≥18 years and legally capable to provide informed consent
- Functioning or non-functioning gastroenteropancreatic (GEP)-neuroendocrine tumor (NET) or unknown primary-NET
- Well differentiated tumor
- Grade (G) 1, G2 according to the 2017 World Health Organization (WHO) criteria
- Subject already treated with Lanreotide Autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study
- Use of Lanreotide autogel® monotherapy by local label (SmPC).
- Concomitant locoregional therapy such as surgery, RFA or TAE is allowed.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhoon Yoo Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.