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| Name | Class |
|---|---|
| METAvivor Research and Support, Inc | UNKNOWN |
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This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.
Primary Aims:
Secondary Aims:
Outline:
Participants will be recruited to participate in the registry during a regularly scheduled clinic visit with their treating oncologist, and consented to participate at this time. At each evaluation time point, participants will have a blood draw performed. Participants will be followed until loss to follow up, death, or withdrawal from the registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Cohort | Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes, for plasma isolation, cell free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within +/- 14 days of whole body imaging studies which will occur when patients are scheduled for standard of care whole body imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Specimen | Procedure | Blood will be drawn via venipuncture |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of registry | Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in >=75% of treating medical oncologists | Up to 2 years |
| Proportion of patients with measurable versus unmeasurable disease | Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist. | Up to 10 years |
| Median Progression Free Survival Rate | The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool. | Up to 10 years |
| Median Overall Survival Rates | The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool. | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who are currently taking estrogen receptor modulators or degraders | The overall proportion of participants who are currently taking estrogen receptor modulators or degraders which may interfere with a radiolabeled form of estradiol (FES) in a positron Emission Tomography (PET) versus the participants medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with histologically proven stage IV invasive lobular carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Venezia Garza | Contact | 415-353-8732 | venezia.garza@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rita Mukhtar, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92053 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples will be obtained from participants
| Up to 10 years |
| Mean Change in Circulating tumor DNA (ctDNA) | The overall change in quantity of ctDNA mean tumor molecules per mL blood versus medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool. | Up to 10 years |
| Number of novel imaging tools | The number of novel imaging tools developed during the course of data collection to improve the determination of disease status will be utilized to develop the ILC specific response assessment tool. | Up to 10 years |
| Number of new tumor markers introduced | The number of participants who have detectable mutations on ctDNA evaluations with are correlated with health outcomes will be utilized to develop the ILC specific response assessment tool. | Up to 10 years |
| Number of participants enrolled in clinical trials | The number of participants with metastatic ILC who have enrolled on a clinical trial will be utilized to develop the ILC specific response assessment tool. | Up to 10 years |
| University of California, San Francisco | Recruiting | San Francisco | California | 94122 | United States |
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| Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |