Observational study on breast cancer detection using autoantibodies against the antigen of cancer stem cells

Observational study on breast cancer detection using autoantibodies against the antigen of cancer stem cells - Autoantibodies for Breast Cancer Detection (ABCD study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045144

Enrollment

350

Registered

2021-08-13

Start date

2020-11-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Correct diagnosis rate, sensitivity, and specificity of autoantibody titer for diagnosis of the presence of breast cancer.	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactDaisuke Kyuno

Sapporo Medical University Department of Pathology and Department of Surgery, Surgical Oncology and Science

kyuno@sapmed.ac.jp0116112111

Outcome results