UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054872 |
|---|---|
| Receipt number | R000062652 |
| Scientific Title | HLA class I expression, a predictor of breast cancer prognosis |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2024/12/31 16:55:13 |
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Basic information
Public title
HLA class I expression, a predictor of breast cancer prognosis
Acronym
HLA class I expression, a predictor of breast cancer prognosis
Scientific Title
HLA class I expression, a predictor of breast cancer prognosis
Scientific Title:Acronym
HLA class I expression, a predictor of breast cancer prognosis
Region
| Japan |
Condition
Condition
operable breast cancer patients
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the level of HLA class I expression in cancer cells and incidentally the involvement of tumor-infiltrating CD8+ T lymphocytes (TILs) in the prognosis of breast cancer patients.
Basic objectives2
Others
Basic objectives -Others
search for biomarker associated with prognosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
overall survival
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
Patients with pathologically confirmed breast cancer
Patients who have undergone breast cancer surgery
Patients for whom information on medical treatment and prognosis can be obtained from the medical record.
Key exclusion criteria
Patients with active other cancers
Patients who have requested not to participate in this study by submitting a publicly available opt-out document.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Departure of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ki, Sapporo City
TEL
+81-11-611-2111
simahiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Departure of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ki, Sapporo City
TEL
+81-11-611-2111
Homepage URL
simahiro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Clinical Trial Center, Sapporo Medical University
Address
S1, W16, Chuo-ku, Sapporo city
Tel
011-611-2111
simahiro@sapmed.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 | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
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
Main results already published
Date of protocol fixation
| 2024 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 05 | Day |
Other
Other related information
Patients with negative HLA class I had significantly poor disease free survival compared with those with positive HLA class I; p=0.04. Univariate analyses revealed that pT, pN, positive lymphatic invasion, and dull/negative HLA class I were significantly associated with DFS. Multivariate analyses revealed dull/negative HLA class I as an independent poor prognostic factor; hazard ratio: 2.23, 95% confidence interval=1.04-4.76, p=0.00385.
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062652
