UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045144 |
|---|---|
| Receipt number | R000051508 |
| Scientific Title | Observational study on breast cancer detection using autoantibodies against the antigen of cancer stem cells |
| Date of disclosure of the study information | 2021/08/13 |
| Last modified on | 2021/08/12 19:53:14 |
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Basic information
Public title
Observational study on breast cancer detection using autoantibodies against the antigen of cancer stem cells
Acronym
Autoantibodies for Breast Cancer Detection (ABCD study)
Scientific Title
Observational study on breast cancer detection using autoantibodies against the antigen of cancer stem cells
Scientific Title:Acronym
Autoantibodies for Breast Cancer Detection (ABCD study)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to measure the levels of autoantibodies against cancer stem cell antigens found in the peripheral blood of breast cancer patients and to analyze their ability to detect breast cancer.
Basic objectives2
Others
Basic objectives -Others
Correct diagnosis rate, sensitivity, and specificity of autoantibody titer for diagnosis of the presence of breast cancer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correct diagnosis rate, sensitivity, and specificity of autoantibody titer for diagnosis of the presence of breast cancer.
Key secondary outcomes
Correlation of autoantibody titer with imaging findings, clinicopathological findings, immunohistological findings, tumor markers, stage, and history of breast cancer
Changes in autoantibody titer before and after treatment
Correlation between each autoantibody titer
Correlation between autoantibody titer and incidence of postoperative recurrence and 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with breast cancer by cytological or pathological diagnosis.
Patients who have obtained the written consent of their own free will with sufficient understanding after receiving sufficient explanation for participation in this study.
Key exclusion criteria
History and comorbidity of malignant or autoimmune diseases
Use of steroids (oral) or immunosuppressive drugs
Patients deemed unsuitable as subjects by the principal investigator
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kyuno |
Organization
Sapporo Medical University
Division name
Department of Pathology and Department of Surgery, Surgical Oncology and Science
Zip code
060-8556
Address
South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan
TEL
0116112111
kyuno@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kyuno |
Organization
Sapporo Medical University
Division name
Department of Pathology and Department of Surgery, Surgical Oncology and Science
Zip code
060-8556
Address
South-1, West-17, Chuo-ku, Sapporo 060-8556, Japan
TEL
0116112111
Homepage URL
kyuno@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Surgical Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Northern Advancement Center for Science and Technology
IRB Contact (For public release)
Organization
IRB, Sapporo Medical University Hospital
Address
South-1, West-16, Chuo-ku, Sapporo 060-8556, Japan
Tel
011-611-2111
ji-rskk@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
| 2021 | Year | 08 | Month | 13 | 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
| 2020 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Observational study in breast cancer patients (cross-sectional study)
Eligible patients
Patients with breast cancer attending or hospitalized in the Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
The planned number of patients will be 300 patients with breast cancer, and 50 patients with benign diseases will be set as the control group.
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051508
