Clinical trial NCT05844332: LUTATHERA Injection General Use Result Survey
Official title: LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Somatostatin Receptor-positive Neuroendocrine Tumor
Keywords: LUTATHERA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with this drug for the following indications during a certain post-marketing period

• Indication: Somatostatin receptor-positive neuroendocrine tumor

Brief summary: This study is a multicenter observational study with a central registration system and all-case surveillance system without a control group.

Detailed description: From the date of the first dose of this drug until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).

For patients who discontinue treatment with this drug during the observation period, necessary variables will be examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (CRF).

Eligibility criteria: Inclusion Criteria:

* All patients treated with this drug for the following indications during a certain post-marketing period

  * Indication: Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study. Patients treated with this drug for off-label indication will also be included in this study to register all patients received this drug.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises
timeFrame: Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Hirosaki
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Kamogawa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Toon city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukushima city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Gifu-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Akashi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kagoshima city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Kamakura
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Suwa
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Osaka Sayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Iwata
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Sunto Gun
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukui
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kobe shi
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Tokushima
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: