UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055308 |
|---|---|
| Receipt number | R000063201 |
| Scientific Title | Development of a Novel Treatment for Cancerous Peritonitis |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2024/08/22 12:29:54 |
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Basic information
Public title
Development of a Novel Treatment for Cancerous Peritonitis
Acronym
Development of a Novel Treatment for Cancerous Peritonitis
Scientific Title
Development of a Novel Treatment for Cancerous Peritonitis
Scientific Title:Acronym
Development of a Novel Treatment for Cancerous Peritonitis
Region
| Japan |
Condition
Condition
Patients with cancerous peritonitis
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
CD4/CD8 T cells in cancer ascites not only express inhibitory receptors (IRs) such as PD1 more frequently than CD4/CD8 T cells in peripheral blood due to long-term exposure to cancer cells (i.e., cancer antigens), but also are considered to be in a 'more exhausted' state. CD4/CD8 T cells in the exhausted stage are refractory to immune-checkpoint-blockade (ICB), which suppresses IRs, and cannot be expected to respond to ICB. The present study,
(1) Development of a novel treatment for patients with refractory cancer ascites by inducing reactivation of exhausted CD4/CD8 T cells by culturing T cells in ascites fluid with a demethylating agent.
(2) Development of a new treatment for patients with refractory cancerous ascites by reactivation of CD4/CD8 T cells using CRISPR/Cas13 technology to suppress PD1 mRNA in T cells.
(3) Development of T cell staging technology by detection of methylation pattern that enables prediction of T cell activation status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of the efficacy of a novel treatment for patients with refractory cancer ascites by inducing the reactivation of exhausted CD4/CD8 T cells by culturing T cells in ascites fluid with a demethylating agent.
Key secondary outcomes
(1) Confirmation of the efficacy of a novel treatment for patients with refractory cancerous ascites by reactivation of CD4/CD8 T cells using a technology that suppresses PD1 mRNA in T cells using CRISPR/Cas13.
(2) Confirmation of the efficacy of T cell staging technology by detection of methylation patterns that can predict the activation state of T cells.
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
Patients diagnosed with cancerous peritonitis and who require a peritoneal puncture
Key exclusion criteria
If the physician determines that the patient is not eligible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Advanced Oncology
Zip code
7010192
Address
577, Matsushima, Kurashiki-city, Okayama
TEL
0864621111
takeshin@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Advanced Oncology
Zip code
7010192
Address
577, Matsushima, Kurashiki-city, Okayama
TEL
0864621111
Homepage URL
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Takeshi Nagasaka
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki-city, Okayama
Tel
0864621111
sentan@med.kawasaki-m.ac.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
川崎医科大学附属病院（岡山）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 28 | 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
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study aims to develop (1) a new treatment for patients with refractory cancer ascites by inducing the reactivation of exhausted CD4/CD8 T cells by culturing T cells in ascites fluid with a demethylating agent, (2) a new treatment for patients with refractory cancer ascites by reactivating CD4/CD8 T cells using a technology to suppress PD1 mRNA in T cells with CRISPR/Cas13, and (3) a new T cell staging technology by detecting methylation patterns to predict T cell activation status.
Management information
Registered date
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063201
