UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050787 |
|---|---|
| Receipt number | R000057874 |
| Scientific Title | Biomarker study of folate receptor alpha(FOLRa)using paired samples of breast cancer tissue |
| Date of disclosure of the study information | 2023/04/09 |
| Last modified on | 2023/04/08 08:43:52 |
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Basic information
Public title
Biomarker study of folate receptor alpha(FOLRa)using paired samples of breast cancer tissue
Acronym
PairFOLRa
Scientific Title
Biomarker study of folate receptor alpha(FOLRa)using paired samples of breast cancer tissue
Scientific Title:Acronym
PairFOLRa
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1. Analyze the expression changes of folate receptor alpha (FOLRa) using breast cancer tumor tissues
2. Explore the relationship between drug resistance in breast cancer and the expression level of FOLRa
Basic objectives2
Others
Basic objectives -Others
1. Analyze the expression changes of folate receptor alpha (FOLRa) using breast cancer tumor tissues
2. Explore the relationship between drug resistance in breast cancer and the expression level of FOLRa
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of the patients with FOLRa-positive breast cancer
Key secondary outcomes
Proportions of cases with increased, unchanged, or decreased IHC scores for FOLRa in paired samples (primary vs. metastatic, pre- vs. post-treatment)
Correlation of FOLRa scores in cell membrane, cytoplasm, and cell membrane + cytoplasm
Association between FOLRa expression and ER/PgR positivity, Ki-67 index, and PD-L1 positivity
Relationship between treatment regimen and changes in FOLRa expression levels
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 20 years or older
2. Pathologically confirmed as triple-negative breast cancer or ER-positive, HER2-negative breast cancer
3. Have undergone tumor collection at two or more different timings, and able to submit tissue samples
Key exclusion criteria
1.Not undergoing systemic therapy
2.Patients deemed unsuitable by a physician for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Sakai |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8146
sakai-h@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Sakai |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8146
Homepage URL
sakai-h@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Junji Tsurutani
Funding Source
Organization
Eisai
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo142-8555, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
昭和大学（東京）、がん研有明病院（東京）、近畿大学（大阪）、名古屋市立大学（愛知）、九州大学病院別府病院（大分）、大阪市立総合医療センター（大阪）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 09 | 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
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study is an observational study conducted using samples and information obtained from routine clinical practice.
Management information
Registered date
| 2023 | Year | 04 | Month | 08 | Day |
Last modified on
| 2023 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057874
