UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055390 |
|---|---|
| Receipt number | R000063262 |
| Scientific Title | Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/09/01 11:59:38 |
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Basic information
Public title
Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture methodPrediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method
Acronym
Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method
Scientific Title
Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method
Scientific Title:Acronym
Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Prediction of therapeutic efficacy based on drug sensitivity of breast cancer stem cells obtained from patient tissue by spheroid culture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spheroid culture is performed using breast cancer tissue derived from patient tissues, and cultured cells are used for drug sensitivity testing.
A small number of three-dimensional cultured cells will be used in the MT Cell Viability Assay, which utilizes the luciferase reaction and allows measurement over time.
The IC50 of each drug will be calculated, and the primary endpoint will be analyzed in relation to the pCR in preoperative chemotherapy patients and the CB in postoperative relapse patients.
Specifically, the IC50 threshold for each drug that yields pCR or CB will be determined from the data of 200 planned cases and used to predict treatment efficacy.
If more than one drug is used, the model that best predicts the treatment effect is determined based on the IC50 of a single drug or a combination of multiple drugs (training data set).
We intend to conduct clinical trials (validation data set) in the future using the models determined here.
Key secondary outcomes
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
Must be 18 years of age or older at the time of consent.
Patients undergoing a mammotome biopsy for a tumor measuring 2cm or larger, or undergoing curative surgery for diagnosed invasive breast cancer.
Must have provided written informed consent for participation in the study.
Key exclusion criteria
Individuals with another malignant disease.
Deemed inappropriate for the study by the principal investigator or co-investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Hidaka |
Organization
Shimane Uiniversity Faculty of Medicine
Division name
Depertment of Digestive and General Surgery
Zip code
6938501
Address
89-1 Enya-cho, Izumo-shi, Shimane Prefecture, Japan
TEL
0853232111
mahidaka@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Miyazaki |
Organization
Shimane Uiniversity Faculty of Medicine
Division name
Depertment of Digestive and General Surgery
Zip code
6938501
Address
89-1 Enya-cho, Izumo-shi, Shimane Prefecture, Japan
TEL
0853-20-2232
Homepage URL
miya445@med.shimane-u.ac.jp
Sponsor or person
Institute
Depertment of Digestive and General Surgery Shimane Uiniversity Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Depertment of Digestive and General Surgery Shimane Uiniversity Faculty of Medicine
Address
89-1 Enya-cho, Izumo-shi, Shimane Prefecture, Japan
Tel
0853-20-2232
miya445@med.shimane-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2034 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study focuses on the importance of drug sensitivity evaluation and personalized treatment in breast cancer therapy. Cancer stem cells play a crucial role in tumor proliferation and metastasis, and their drug resistance increases the risk of recurrence. We have successfully cultured breast cancer stem cells selectively using the spheroid culture method in over 50 clinical samples. Utilizing this technique, we aim to evaluate the drug sensitivity of patient-derived cancer stem cells in vitro and predict the effectiveness of preoperative chemotherapy. Ultimately, the study seeks to establish an optimal personalized drug selection system.
Management information
Registered date
| 2024 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063262
