Core Biopsies of Breast Tumor Tissue Repository
PRIMARY OBJECTIVES:
I. To develop a baseline and serial breast cancer core biopsy repository within the
University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer
Program.
II. To develop and maintain a secure clinical database of relevant demographic, clinical,
pathologic and longitudinal outcome characteristics of the samples to be banked.
III. To have an efficient process for the distribution of de-identified samples from the bank
to researchers with institutional review board (IRB)-approved protocols or exemptions for the
study of breast cancer-related questions. These studies would include analyses of tumor
proteins and nucleic acids, serum/plasma and germline deoxyribonucleic acid (DNA) and immune
cells in relationship to other baseline and follow-up clinical and pathological variables.
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT I (PATIENTS WITH NEWLY DIAGNOSED EARLY STAGE BREAST CANCER WHO WILL UNDERGO DEFINITIVE
SURGERY BEFORE ANY SYSTEMIC THERAPY): Patients undergo baseline and, if applicable, follow-up
core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases.
Patients who experience a recurrence or progression after therapy undergo additional core
biopsies at the time of recurrence. Clinical and blood specimens will also be gathered.
COHORT II (PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER WHO WILL RECEIVE STANDARD OF CARE
SYSTEMIC THERAPY BEFORE SURGERY OR PATIENTS WITH ADVANCED UNRESECTABLE DISEASE): Patients
undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also
undergo biopsies at a specific time point following the initiation of standard systemic
therapy.
COHORT III (PATIENTS BEING EVALUATED FOR A SUSPICIOUS BREAST MASS THAT HAS A HIGH LIKELIHOOD
OF BEING CANCER): Patients undergo core biopsy, clinical, and blood sample collection as in
Cohort I. Patients who have Breast Imaging-Reporting and Data System (BIRADS) 4b, 4c, and 5
lesions may undergo up to 6 additional 6 core biopsies.
COHORT IV (PATIENTS WITH BREAST CANCER RECURRENCE OR PROGRESSION [LOCAL, REGIONAL, OR
DISTANT/METASTATIC]): Patients undergo core biopsy, clinical, and blood sample collection as
in Cohort I. Patients may also undergo 1-3 extra core biopsies.
After completion of study, patients are followed up every 6 months.
Longitudinal Advanced Prostate Cancer Cohort (LAPCC)
PRIMARY OBJECTIVE:
I. To create an annotated biorepository with prospectively collected blood and urine samples
from men with advanced prostate cancer.
OUTLINE: This is an observational study.
Patients undergo blood and urine sample collection, complete surveys, and have their medical
records reviewed on study.
Project FIRE: Understanding the health effects of wildfires
Wildfire seasons are increasing in length and frequency, putting more people at risk to the effects of wildfire smoke. Project FIRE (Fire Impact REsearch) aims to investigate the acute effects of wildfires on human health. To this end, we have developed a smartphone application (app) that will be made freely available to our study participants. We will use this app to collect data on smoke exposure and health symptoms before, during, and after a wildfire. The findings from this study will help us understand how wildfires affect people’s health so that ultimately, we can better prepare for future wildfires and minimize health risks to communities.
Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
Skin diseases account for 30% of all physician office visits. In the United States, access to
dermatologists remains a significant challenge for those in underserved or rural communities.
To increase access to specialists and improve patient outcomes, we will evaluate a team-based
connected health (TCH) model that enables structured asynchronous online interactions among
patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable
effective management of chronic skin diseases via high-quality and efficient online care
between providers and patients. TCH purports to bring direct and expedient specialist care to
patients and PCPs in a location-independent and asynchronous manner.
Specifically, TCH offers several ways that patients and providers can communicate online
asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and
(3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access
dermatologists online asynchronously for consultations or to request a dermatologist to
assume care of patient's skin disease. With patient-dermatologist interactions, patients can
upload clinical images and history online and obtain asynchronous evaluation and
recommendations from dermatologists directly. Finally, PCPs have the option of managing their
patients' skin diseases online. Importantly, TCH applies efficient workflow that maximally
supports providers and fosters multi-directional, informed communication among patients,
PCPs, and dermatologists.
To evaluate the impact of TCH, we use atopic dermatitis (AD) as a disease model. AD is a
common, relapsing inflammatory skin disease affecting 32 million individuals in the U.S. AD
is characterized by intense itching and red, scaly patches. It incurs significant morbidities
and high healthcare costs. To address skin inflammation, itch, and psychosocial consequences,
PCPs and dermatologists need to adopt a team-based approach to effectively manage all aspects
of AD.
The primary goal of the proposed research is to test whether the online TCH model results in
equivalent improvements in disease severity and quality of life, provides better access to
specialist care, and is cost- saving as compared to usual in-person care in pediatric and
adult patients with AD. Specifically, we will conduct a pragmatic, cluster-randomized
controlled equivalency trial and use validated measures to compare AD disease severity,
health-related quality of life, and access to care between TCH and in-person care. We will
also compare costs of the two healthcare delivery models from a societal perspective by
conducting cost- minimization and sensitivity analyses.
This proposal evaluates a significant innovation in specialty-care delivery that will likely
result in improved patient outcomes, greater access to specialists, and cost savings. The
study findings will be highly impactful and have immense dissemination potential to the
management of many other chronic diseases.
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization
will be stratified by upper arm or forearm placement based on the investigator's
determination of where the study access (SA) should be located. Subjects will be followed to
24 months post SA creation at routine study visits regardless of patency status. After 24
months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up
to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV
subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation
at routine study visits.
Dual Mobility Acetabular Cups in Revision TJA
The aim of this study is to the compare clinical outcomes of patients undergoing a revision
total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing
design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of
dual-mobility components in revision THA will be associated with a lower dislocation rate in
the first year following surgery.
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The PORTICO pivotal IDE trial will include a randomized cohort of 750 subjects enrolled at up
to 70 investigational sites in the United States and Australia. Patients will be randomized
(1:1) to receive the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) or
any FDA-approved, commercially-available Transcatheter Aortic Valve Replacement (TAVR)
System. The randomized cohort will be tested for two co-primary endpoints at 30 days (primary
safety endpoint) and 1 year (primary effectiveness endpoint). At the time of the primary
randomized cohort analysis, the risk cohorts will be combined and analysis will be conducted
on the intention-to-treat (n=750) population.
The FlexNav Delivery System study will be conducted as a separate arm of the PORTICO IDE
trial and will include up to 200 high or extreme risk subjects; including a minimum of 100
analysis subjects. The study will characterize the safety of the next-generation Portico
Delivery System ("FlexNav™ Delivery System"). The primary analysis cohort will include
FlexNav analysis subjects.
The IDE Valve-in-Valve registry will enroll up to 100 high or extreme risk subjects with a
failed surgical bioprosthesis who are eligible to receive a Portico Transcatheter Heart
Valve.
All subjects enrolled in the PORTICO pivotal IDE trial will undergo follow-up at baseline,
peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30
days, 6 months, 12-months and then annually through 5-years.
Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
This study aims to compare the clinical outcomes of patients considered to be at high risk
for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a
dual mobility bearing versus a conventional, single-bearing design.
We hypothesize that in primary THA patients considered to be at high risk for prosthetic
dislocation, the use of dual-mobility components will be associated with a lower dislocation
rate in the first year following the index procedure. We do not anticipate a difference. In
other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
Protocol for Immunology Specimen Collection From Cancer Patients, Patients With Hematologic Diagnoses, and Healthy Normal Controls
PRIMARY OBJECTIVES; I. Identify changes in immune system parameters in patients receiving
immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory
agents, cellular therapies, stem cell transplantation) and compare to changes in patients
receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers
using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification,
functional analysis of immune cell subsets isolated via fluorescence activated cell sorting
(FACS), and genetic and proteomic techniques (deoxyribonucleic acid [DNA] sequencing,
ribonucleic acid sequence [RNASeq], reverse transcriptase-polymerase chain reaction [RT-PCR],
Western blot).
SECONDARY OBJECTIVES:
I. Optimize methods for measuring functional status of circulating immune cells and
hematopoietic progenitors (activation, inhibition, cytotoxicity, proliferative capacity).
II. Use genetic and epigenetic techniques to a) study clonal diversity in T cell subsets b)
determine the genetic basis for T cell immune reconstitution following stem cell
transplantation.
OUTLINE:
Patients and healthy normal volunteers undergo collection of peripheral blood samples for
analysis via flow cytometry, RNASeq, immunohistochemistry, cytometry by time of flight
(CyTOF) experiments, cell cultures, and functional studies of immune cell subsets obtained by
FACS. Patients also undergo collection of bone marrow and leukopheresis/leukoreduction
specimens, and single cell suspensions and bulk excised tumor biopsies are obtained from
routine testing for analysis via immunohistochemistry or CyTOF.
After completion of study, patients are followed up for up to 2 years.
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)
The study will consist of two phases, I and II.
Phase I will include patients with metastatic TNBC, HER2/neu-negative and hormone resistant
breast cancer. A total of 4 doses of sarilumab will be given with the starting dose of 150 mg
SQ at 3-weeks cycles given 3 days prior to each of the first 4 of 8 cycles of capecitabine
(1000 mg/m2/BID; for 14 days every 21 days). If dose escalation is possible, sarilumab will
be administered every 3 weeks at 200 mg SQ for 4 doses. Blood samples will be obtained prior
during the course of treatment. Bone marrow samples are optional.
Phase II is a single arm study in Stage I to III TNBC with less than a complete pCR after
neoadjuvant therapy evaluating the combination of sarilumab with capecitabine (1000mg/m2/BID;
for 14 days every 21 days) as compared to historical control patients treated with
capecitabine alone. There are 8 cycles of capecitabine. The first 4 cycles will be combined
with sarilumab. The Phase II sarilumab dose will be determined by the Phase I best tolerated
dose. Blood samples will be obtained prior during the course of treatment. Bone marrow
samples are optional.
A pilot parallel biological baseline study of standard adjuvant capecitabine in stage I to
III TNBC with less than a pCR will be performed. This Arm will be open in parallel with both
Phases 1 and 2. Blood samples will be obtained prior during the course of treatment. Bone
marrow samples are optional.
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