Breast Cancer Organoids Clinical Trial
Official title:
Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture
| Verified date | March 2019 |
| Source | Xijing Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Based on the breast cancer organ platform, this experiment establishes a drug sensitivity test method that is closer to the body tumor in breast cancer, provides a basis for the accurate treatment of breast cancer, and discusses the possible mechanism of breast cancer drug resistance.
| Status | Enrolling by invitation |
| Enrollment | 300 |
| Est. completion date | December 15, 2021 |
| Est. primary completion date | December 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Patients with breast cancer and the largest tumor diameter = 3cm No previous chemotherapy regimen age 18-65 years old Can obtain the tumor tissue specimens required for culture Heart, liver, kidney and bone marrow hematopoietic function is good Know and sign the informed consent form Exclusion Criteria: Pregnant or lactating women Also suffering from other cancer patients There are serious uncontrolled medical diseases or acute infections Those who are known to be allergic to this study drug or a variety of previous drugs The patient cannot understand the purpose of the study or disagree with the requirements of the study. Other investigators believe that patients who are not suitable for this study group |
| Country | Name | City | State |
|---|---|---|---|
| China | JingSu | Xi'an | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Xijing Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Detection of cell viability | 1. The organ-like organ was assayed for cell viability using CellTiter Glo 3D reagent, and the curve was used to obtain a half-inhibitory concentration range. The dose was adjusted according to the half-inhibition concentration range to obtain an accurate half-inhibitory concentration. | 8 weeks before neoadjuvant chemotherapy | |
| Secondary | Detection of in vitro model drug sensitivity | 2. In vitro model drug sensitivity: sensitive and insensitive | 8 weeks before neoadjuvant chemotherapy | |
| Secondary | Clinical efficacy assessment according to RECIST criteria | Clinical efficacy evaluation according to RECIST criteria: imaging ultrasonography, histological pathology. | 8 weeks before neoadjuvant chemotherapy |