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ProtocolTrial Name and Objective
040703

Significance of Single Nucleotide Polymorphisms in Breast Cancer Patients Undergoing Radiation Therapy

In a cohort of approximately 250 women, diagnosed with breast cancer and treated with breast conserving surgery or mastectomy and radiation we will evaluate the frequency of this polymorphism (SNP309). We will correlate the polymorphism status with other clinical, pathologic and genetic information we have on these 250 women, including but not limited to stage, age of onset of disease, receptor status, her2 status, and the status of BRCA1 and BRCA2. We will recruit additional patients with a new diagnosis of breast cancer to correlate the status of SNP309 with other clinical and pathological variables.
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001408

Molecular and Genetic Markers in the Local-regional management of patients undergoing radiation therapy

1. To determine if molecular markers correlate with local relapse in patients undergoing radiation
2. To compare molecular factors with other clinical-pathologic factors
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041207

Cardiovascular Morbidity and Mortality after Breast Cancer Treatment

1. Purpose/Specific Objectives
The purpose of the proposed study is to characterize the impact of breast cancer related loco-regional treatment (e.g. surgery (lumpectomy & mastectomy) or radiation therapy) on cardiovascular outcomes and/or cerebrovascular disease in New Jersey.

The overall goal is to study the relationship of breast cancer loco-regional treatment (surgery or radiation therapy) related to cardiovascular and/or cerebrovascular diseases, treatment, environmental and familial factors with respect to long-term outcomes in terms of morbidity and mortality in New Jersey breast cancer patients. Use of procedures, readmissions, death and cause of death are the main outcome measures.

1.1 Primary Endpoint
* To examine the rate of cardiovascular outcomes (Using ICD9 codes 410-414, and 420-429) between breast cancer patients who had radiation therapy for breast cancer (Using ICD9 codes 233, 174, and 175). We will compare left versus right breast cancer patients.
* To examine the rate of cardiovascular outcomes (Using ICD9 codes 410-414, and 420-429) between breast cancer patients (Using ICD9 codes 233, 174, and 175) who did not have radiation therapy for breast cancer.
1.2 Secondary Endpoints
* The differences between sub-groups compared to the reference group (lacking the factor(s) under consideration; i.e. a matched cohort of patients who were not treated for breast cancer) will be investigated by looking at the data longitudinally.
* Future studies may focus on systemic interrelationships between disease incidence, treatment, environmental parameters, etc., and address possible consequences of changes in breast cancer treatment over time on the incidence of cardiovascular and cerebrovascular disease morbidity and mortality after breast cancer treatment.
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131304

Radiation from Interventional Cardiovascular Procedures and Risk of Breast Cancer

Hypothesis: The primary hypotheses underlying this project are as follows: (1) Exposure to IR delivered during ICPs will lead to an increased risk of developing breast cancer in our cohort of patients and (2) As ICPs have become longer and more complex, the procedural changes over time may increase the relative risk of developing breast cancer.

Aim 1: To quantitate the exposure to IR delivered to patients in New Jersey who underwent interventional cardiovascular procedures.
Aim 1A: To calculate population based rates of low, moderate, high, and very high effective doses of IR from interventional cardiovascular procedures.
Aim 1B: To describe the specific types of interventional cardiovascular procedures among persons for whom the long-term risks of IR exposure are most relevant.

Aim 2: To quantitate the risk of developing breast cancer in patients admitted for cardiovascular disease in New Jersey who had received IR from interventional cardiovascular procedures by linking MIDAS with the NJSCR. We will compare the risk of developing breast cancer in patients exposed to IR (ICP group) and unexposed patients (non-ICP group).
Aim 2A: To link the MIDAS groups from Aim 1 to the NJSCR, and classify cohort members by breast cancer diagnosis.
Aim 2B: To longitudinally compare the IR exposed group with the matched unexposed group of patients who did not receive IR from interventional cardiovascular procedures.
Aim 2C: To estimate the risk of developing breast cancer based on rates of low, moderate, high, and very high effective doses of radiation from interventional cardiovascular procedures.

Aim 3: To determine systemic interrelationships between changes in interventional cardiovascular procedures over time on the incidence of breast cancer and associated rates of morbidity and mortality.
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131316

Project SOL - Sun Safety for Outdoor Laborers

The goal of this project is to develop and test a culturally relevant sun safety education program for the Hispanic outdoor day laborer population who work or reside in the Greater New Brunswick (New Jersey) area. Although little is known about the incidence of skin cancer among Hispanic outdoor day laborers, ultraviolet radiation (UVR) exposure is a key risk factor for both
melanoma and non-melanoma skin cancers, and outdoor day laborers spend a large amount of their work exposed to UVR. The incidence of melanoma has steadily increased among U.S. Hispanics in recent years.
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031205

The Possible Role of ERCC1 in Determining Patterns of Recurrence after Chemoradiation for Lung Cancer

This study intends to characterize ERCC1 overexpression in predicting local recurrence of non-metastatic lung cancer and pancreas cancer treated with radiation therapy (RT) with or without chemotherapy. It is hypothesized that higher ERCC1 levels would allow for improved repair capacity and higher chance of local recurrence after radiation therapy
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111003

COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

1. To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy with vincristine, cisplatin, etoposide and cyclophosphamide (VCEC).

2. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by a) post-operative induction chemotherapy or by b) second surgery who will then be non-randomly assigned to cRT followed by four cycles of maintenance chemotherapy (VCEC)

3. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection or children who achieve a CR to short course induction chemotherapy following first surgery.
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101301

A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174)

The aim of this study is to test the potential benefit of the addition of adjuvant chemotherapy following completion of primary chemoradiation for patients with locally advanced cervical cancer.
The primary objective will be to determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.
Secondary objectives will be to determine:
 Progression-free survival rates
 Acute and long-term toxicities
 Patterns of disease recurrence
 The association between radiation protocol compliance and outcomes
 Patient quality of life, including psycho-sexual health
Tertiary objectives will be to determine:
 The association between the results of a follow-up PET scan performed 4 - 6 months post completion of chemo-radiation and outcomes for all patients in the trial
 Biological predictors of patients outcomes based on translational laboratory studies of blood and tissue specimens
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091312

A safety study for MSB0010445 in combination with Stereotactic Body Radiation in advanced melanoma subjects following prior treatment with ipilimumab

The primary objective of the trial is as follows:
- To determine the maximum tolerated dose (MTD) of MSB0010445 in combination with Stereotactic Body Radiation Therapy (SBRT) in subjects with advanced melanoma
The exploratory objectives of the trial are as follows:
- To establish that MSB0010445 in combination with SBRT is clinically active through the observation of best overall response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- To further characterize the safety of MSB0010445 in combination with SBRT
- To characterize the immunogenicity of MSB0010445
- To characterize the pharmacokinetics (PK) of MSB0010445
- To propose that MSB0010445 in combination with SBRT is biologically active by observing modifications of the tumor microenvironment (by infiltration of CD8+ T cells and of regulatory T cell [Treg] in the tumor)
- To evaluate potential biomarkers of immune response correlated with clinical activity by analysis of tumor and peripheral blood samples
- To establish that MSB0010445 is clinically active through the observation of best overall response assessed by modified immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- To evaluate the pharmacodynamic activity of MSB0010445 in combination with radiotherapy in peripheral blood
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