UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049890 |
|---|---|
| Receipt number | R000056705 |
| Scientific Title | Prospective observational study to evaluate the utility of functional assessment scoring in patients with unresectable or advanced recurrent pancreatic cancer |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2023/06/27 10:03:04 |
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Basic information
Public title
Prospective observational study to evaluate the utility of functional assessment scoring in patients with unresectable or advanced recurrent pancreatic cancer
Acronym
Prospective observational study to evaluate the utility of functional assessment scoring in patients with unresectable or advanced recurrent pancreatic cancer
Scientific Title
Prospective observational study to evaluate the utility of functional assessment scoring in patients with unresectable or advanced recurrent pancreatic cancer
Scientific Title:Acronym
Prospective observational study to evaluate the utility of functional assessment scoring in patients with unresectable or advanced recurrent pancreatic cancer
Region
| Japan |
Condition
Condition
unresectable or advanced recurrent pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of the study is to clarify the functional assessment scoring and regimen selection status of patients with unresectable or advanced recurrent pancreatic cancer, and to examine the relationship between functional assessment scoring and treatment efficacy and tolerability, and possible prognostic factors.
Basic objectives2
Others
Basic objectives -Others
We will also analyze the relationship between the scoring and previously reported prognostic factors such as Neutrophil to lymphocyte ratio (NLR) and CRP-to-albumin ratio (CAR).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional assessment scoring and regimen selection, association with tolerability, and possible prognostic factors
Key secondary outcomes
Association of inflammatory and immune markers and body composition assessment with prognosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with unresectable or recurrent pancreatic cancer who have been diagnosed as pancreatic cancer based on histological, imaging or clinical findings.
2) Patients who have been fully informed about the study and have given their written consent.
Key exclusion criteria
1) Patients who are deemed by the treating doctor to be unsuitable for enrollment in this study.
2) Patients with pathologically diagnosed neuroendocrine tumor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nishina |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of Gastrointestinal Medical Oncology
Zip code
7910280
Address
160 Kou, Minami-umemoto, Matsuyama, Ehime
TEL
0899991111
nishina.tomohiro.nj@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Hino |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of Gastrointestinal Medical Oncology
Zip code
7910280
Address
160 Kou, Minami-umemoto, Matsuyama, Ehime
TEL
0899991111
Homepage URL
hino.kaori.mw@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University Hospital, Matsuyama Red Cross Hospital, Ehime Prefectural Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Shikoku Cancer Center
Address
160 Kou, Minami-umemoto, Matsuyama, Ehime
Tel
0899991111
hino.kaori.mw@mail.hosp.go.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
独立行政法人国立病院機構四国がんセンター（愛媛県）、愛媛大学医学部附属病院（愛媛県）、松山赤十字病院（愛媛県）、愛媛県立中央病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Pre-treatment evaluation
1) Sex, age (at diagnosis), height, weight
2) Family history of cancer
3) Cancer history, treatment history, and underlying disease
4) Stage of cancer, presence or absence of primary tumor resection, date of primary tumor resection, presence or absence of perioperative chemotherapy (if yes, treatment history)
5) Pathological histology
6) Site of metastasis (presence or absence of distant metastasis, lymph node, liver, lung, bone, peritoneum, other)
7) Presence or absence of target lesions in RECIST version 1.1
8) Degree of ascites accumulation (none, small volume, moderate volume, severe)
Small volume: confined to pelvic cavity/upper abdomen.
Moderate volume: other than small volume and severe ascites.
Severe: continuous from the pelvic region to the upper abdomen.
9) Biliary drainage
10) Body composition evaluation
Psoas muscle mass index (PMI)
Psoas index (PI)
2. Regimen-specific survey
1) Regimen content and treatment line
2) Reason for regimen selection
3) Degree of ascites accumulation (none, small, moderate, severe)
4) UGT1A1 gene polymorphisms if modified FOLFIRINOX or nal-IRI therapy is selected
5) ECOG PS before starting therapy, PS at discontinuation of therapy, weight, date of starting therapy, presence of exacerbation, date of exacerbation, date of discontinuation, reason for discontinuation of therapy (PD, adverse events, etc.), effect of tumor reduction
6) Dose, etc
7) Grade 3 or higher toxicity in CTCAE ver5.0
8) Presence or absence of biliary drainage
9) Blood tests at start and discontinuation of therapy (neutrophil count, lymphocyte count, mononuclear cell count, platelet count, albumin, AST, ALT, T-bil, Cre, CRP, CEA, CA19-9)
10) Functional assessment at the beginning and discontinuation of therapy: G8 and EQ-5D-5L investigations.
3. Genetic testing
BRACAnalysis, MSI status
4. Outcome
Date of last confirmed alive, date of death, cause of death
Management information
Registered date
| 2022 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056705
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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