UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051641 |
|---|---|
| Receipt number | R000058926 |
| Scientific Title | Real-world evidence on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) long-term survival after treatment with liposomal irinotecan |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2024/01/18 10:14:44 |
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Basic information
Public title
Real-world evidence on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) long-term survival after treatment with liposomal irinotecan
Acronym
NALLONG
Scientific Title
Real-world evidence on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) long-term survival after treatment with liposomal irinotecan
Scientific Title:Acronym
NALLONG
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
Metastatic pancreatic ductal adenocarcinoma (mPDAC)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Key objectives:
1. Characterize the population according to patient demographics: age, gender, height, weight, current vital status
- Patient characteristics at mPDAC diagnosis: comorbidities, co-medications, risk factors, etc.
- Disease characteristics at PDAC and/or mPDAC diagnosis and each line initiation (if different): diagnosis dates and stage (localized/locally advanced/metastatic), tumor location, metastasis, mutation status, ECOG PS, etc.
2. Characterize and identify mPDAC treatment by line of treatment from diagnosis to last treatment (and best supportive care [BSC] if any),
- Surgery (type, setting, date), radiation therapy (type, setting, start and end dates), systemic treatments (treatment start and end dates, treatment interruptions and their reasons)
- Efficacy outcomes of systemic treatments based on OS and PFS (overall and by line)
- Tolerability outcomes of systemic treatments according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0): All grade 3/4 adverse drug reactions (ADRs), ADRs leading to treatment discontinuation or modification
Basic objectives2
Others
Basic objectives -Others
Explore prognostic factors of OS and PFS in mPDAC long-term survivors using duration of treatment and subgroup stratification
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
Not Applicable as data collection is performed to describe population, disease and treatment characteristics.
Key secondary outcomes
Not Applicable as data collection is performed to describe population, disease and treatment characteristics.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult Patients must meet all the following inclusion criteria to be eligible for the study:
1. 18 years and older (19 years and older for South Korea)
2. Cytologically confirmed mPDAC at initiation of nal-IRI treatment
3. All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
4. Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
5. At least one cycle of nal-IRI-containing regimen should have been administered
6. A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
7. Availability of data related to survival outcomes in the patient medical record
8. Patients deceased or not at the time of enrollment will be eligible for inclusion in the study
Key exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
1. No documentation of systemic therapy outcomes or prior treatments in patient medical records
2. Patients with second concomitant metastatic malignancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Kanagawa Cancer Center
Division name
Department of Gastroenterology
Zip code
241-8515
Address
2-3-2 Nakao Asahi-ku Yokohama city, Kanagawa Pref, 241-8515
TEL
045-520-2222
kantansui-renkei@kcch.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Otani |
Organization
Linical Co., Ltd.
Division name
Contract Medical Affairs Business unit
Zip code
105-0021
Address
18th Shiodome Sumitomo Building,9-2, Higashi-shimbashi 1-chome, Minato-ku,Tokyo 105-0021, Japan
TEL
03-6215-8005
Homepage URL
otani-satoko@linical.co.jp
Sponsor or person
Institute
Servier Affaires Medicales
Institute
Department
Personal name
Funding Source
Organization
Servier Affaires Medicales
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
FRANCE
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center Research Ethics Review Committee
Address
2-3-2 Nakao Asahi-ku Yokohama city, Kanagawa Pref, 241-8515
Tel
045-520-2222
clinical_trials@kcch.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
地方独立行政法人 神奈川県立病院機構 神奈川県立がんセンター（神奈川県）
Kanagawa Cancer Center
国立研究開発法人 国立がん研究センター 中央病院（東京都）
National Cancer Center Hospital
国立研究開発法人 国立がん研究センター 東病院（千葉県）
National Cancer Center Hospital East
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058926
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