- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05844332
LUTATHERA Injection General Use Result Survey
LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
Study Contact Backup
- Name: Novartis Pharmaceuticals
- Phone Number: +81337978748
- Email: novartis.email@novartis.com
Study Locations
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Chiba, Japan, 260-8717
- Novartis Investigative Site
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Fukui, Japan, 910-8526
- Novartis Investigative Site
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Fukuoka, Japan, 814-0001
- Novartis Investigative Site
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Hiroshima, Japan, 734-8551
- Novartis Investigative Site
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Kyoto, Japan, 606 8507
- Novartis Investigative Site
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Niigata, Japan, 951-8566
- Novartis Investigative Site
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Osaka, Japan, 545-8586
- Novartis Investigative Site
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Osaka, Japan, 553-0003
- Novartis Investigative Site
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Tokushima, Japan, 770-8503
- Novartis Investigative Site
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Yamagata, Japan, 990 9585
- Novartis Investigative Site
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Aichi
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Nagoya, Aichi, Japan, 464 8681
- Novartis Investigative Site
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Aomori
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Hirosaki, Aomori, Japan, 036 8563
- Novartis Investigative Site
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Chiba
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Kamogawa, Chiba, Japan, 296-8602
- Novartis Investigative Site
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Kashiwa, Chiba, Japan, 277 8577
- Novartis Investigative Site
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Ehime
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Toon city, Ehime, Japan, 791-0295
- Novartis Investigative Site
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Fukuoka
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Fukuoka city, Fukuoka, Japan, 812-8582
- Novartis Investigative Site
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Fukushima
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Fukushima city, Fukushima, Japan, 960 1295
- Novartis Investigative Site
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Gifu
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Gifu-city, Gifu, Japan, 501-1194
- Novartis Investigative Site
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Gunma
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Maebashi city, Gunma, Japan, 371 8511
- Novartis Investigative Site
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8543
- Novartis Investigative Site
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Sapporo city, Hokkaido, Japan, 060 8648
- Novartis Investigative Site
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Hyogo
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Akashi, Hyogo, Japan, 673-8558
- Novartis Investigative Site
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Kobe-city, Hyogo, Japan, 650-0047
- Novartis Investigative Site
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Kobe-shi, Hyogo, Japan, 650-0017
- Novartis Investigative Site
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Ishikawa
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Kanazawa-city, Ishikawa, Japan, 920-8641
- Novartis Investigative Site
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Kagawa
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Kita-gun, Kagawa, Japan, 761-0793
- Novartis Investigative Site
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Kagoshima
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Kagoshima city, Kagoshima, Japan, 890 8520
- Novartis Investigative Site
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Kanagawa
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Kamakura-city, Kanagawa, Japan, 247-8533
- Novartis Investigative Site
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Yokohama-city, Kanagawa, Japan, 236-0004
- Novartis Investigative Site
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Kumamoto
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Kumamoto City, Kumamoto, Japan, 860-8556
- Novartis Investigative Site
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Miyagi
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Sendai city, Miyagi, Japan, 980 8574
- Novartis Investigative Site
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Nagano
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Suwa, Nagano, Japan, 392-8510
- Novartis Investigative Site
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Okayama
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Kurashiki-city, Okayama, Japan, 710-8602
- Novartis Investigative Site
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Okayama-city, Okayama, Japan, 700-8558
- Novartis Investigative Site
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Osaka
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Osaka Sayama, Osaka, Japan, 589 8511
- Novartis Investigative Site
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Osaka-city, Osaka, Japan, 541-8567
- Novartis Investigative Site
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Suita, Osaka, Japan, 565 0871
- Novartis Investigative Site
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Shizuoka
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Hamamatsu-city, Shizuoka, Japan, 431-3192
- Novartis Investigative Site
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Iwata City, Shizuoka, Japan, 438-8550
- Novartis Investigative Site
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Shizuoka-city, Shizuoka, Japan, 420-8527
- Novartis Investigative Site
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Sunto Gun, Shizuoka, Japan, 411 8777
- Novartis Investigative Site
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8519
- Novartis Investigative Site
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Chuo ku, Tokyo, Japan, 104 0045
- Novartis Investigative Site
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Koto ku, Tokyo, Japan, 135 8550
- Novartis Investigative Site
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Toyama
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Toyama-city, Toyama, Japan, 930-0194
- Novartis Investigative Site
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Yamanashi
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Chuo-city, Yamanashi, Japan, 409-3898
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
All patients treated with this drug for the following indications during a certain post-marketing period
• Indication: Somatostatin receptor-positive neuroendocrine tumor
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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LUTATHERA
patients treated with LUTATHERA Injection
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There is no treatment allocation.
Patients administered LUTATHERA by prescription can be enrolled.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises
Time Frame: Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).
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To evaluate the safety about Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises after administration of this drug in a real world setting
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Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAA601A11401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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