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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09773 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-0669 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| Artidis | INDUSTRY |
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This study assesses changes to the immune cells following hypofractionated radiation-induced DNA damage in breast cancer patients. Radiation therapy may cause immune cells to enter tumors and target cancer cells. The goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.
PRIMARY OBJECTIVE:
I. To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy).
SECONDARY OBJECTIVE:
I. To estimate the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline.
II. To examine cancer cell intrinsic immune signaling following radiotherapy.
EXPLORATORY OBJECTIVE:
I. To examine the association between DNA damage and micronuclei formation. II. To examine the association between DNA damage and immune infiltration. III. To examine the association between micronuclei formation and immune infiltration.
OUTLINE:
Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (RT, biopsy) | Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo tumor punch biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of CD8+ T cells | Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals. | Baseline up to day 8 |
| Percent change of CD4+ T cells | Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals. | Baseline up to day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer that appears to be superficially accessible to a tumor punch biopsy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simona F Shaitelman, MD | Contact | (713) 563-8491 | sfshaitelman@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Simona F Shaitelman, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Tissue
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
|
| Radiation Therapy | Radiation | Undergo RT |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |