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ProtocolTrial Name and Objective
131307

Couple-Focused Intervention for Colorectal Cancer Screening

Specific Aim 1:To compare the efficacy of three interventions: Enhanced Couple-Tailored Intervention (E-CTI), an Enhanced Couples' Generic Intervention (E-GCI), and a Generic Print Intervention (GP) on couples' CRCS.
Hypothesis:CRCS rates at follow-up will be 22-30% in E-CTI, 12-15% in E-GCI, and 8% in GP.

Specific Aim 2:To evaluate the individual (perceived risk, decisional balance, planning, intentions) and relationship-level (relationship perspective, support for spouse screening, couples'discussions) factors which mediate E-CTI effects on couples' CRCS when compared with E-GCI and GP.
Hypothesis: E-CTI will result in significantly higher risk, more positive decisional balance, greater planning, higher CRCS intentions, adoption of greater relationship perspective on CRCS, more support for the partner's CRCS, and more frequent CRCS discussions when compared with E-GCI and GP, and that the meditational effect will be stronger in E-CTI.

Exploratory Aim: To evaluate the individual (gender, baseline intentions, support for spouse's screening, insurance status) and relationship-level (marital quality) factors which moderate E-CTI effects on couples' CRCS practices when compared with E-GCI and GP.
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131501

Improving Patient Access to Quality Cancer Treatment (IMPACT)

Specific Aims for Phase I
Develop a survey instrument to collect data on pre- Patient Protection and Affordable Care Act (PPACA) implementation and early phase implementation that may affect access to cancer care, treatment patterns, and outcomes in New Jersey.
a) Examine disparities in access to care and patient experiences among cancer cases by insurance type, comorbidities and various demographic subgroups.
b) Examine the prevalence of concurrent medication use among cancer cases who are undergoing or have undergone cancer-related drug therapies (e.g. chemotherapy, hormone therapy)

Specific Aims for Phase II

1. Use pilot data derived from this project to demonstrate the feasibility and value of collecting population-based patient survey data on New Jersey cancer cases.
2. Expand the survey data collection to New Jersey cancer cases diagnosed and treated in later years to further examine the impact of PPACA implementation (e.g. Medicaid expansion) on access to care.
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051406

NCI/CTEP #9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinic) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer

Primary Objective: To determine the maximum tolerated dose (MTD)and dose-limiting toxicities (DLT) of the combination of AZD6244 and cyclosporin A in adult patients with advanced solid tumors.
Seconday Objectives: (1) To determine the safety profile and tolerability of thsi regimen in this patient population. (2) To determine the pharmacokinetics of the combination. (3) To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or metastatic CRC. (4) Evaluate the activity of the combination in terms of objective response rate (per RECIST 1.1), overall survival, and progression-free survival.
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051508

Protocol #: 20140318: A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

The primary objective of the study is to evaluate the maximum tolerated dose (MTD) of intrahepatic injection of talimogene laherparepvec into tumors of the liver, based on subject incidence of dose-limiting toxicities (DLTs), separately in subjects with primary hepatocellular carcinoma (HCC) and subjects with metastatic liver tumors (non-HCC).
The secondary objectives of the study are as follows:
* To evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver
tumors as assessed by subject incidence of treatment-emergent and
treatment-related adverse events
* To evaluate the efficacy of intrahepatic injection of talimogene laherparepvec in the overall population and by tumor type (non-HCC and HCC) as assessed by: objective response rate (ORR), best overall response (BOR), durable response rate (DRR), duration of response (DOR), response in injected and uninjected lesions, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
* To estimate the incidence of detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in blood and urine
* To estimate the incidence of clearance of talimogene laherparepvec DNA from blood and urine
* To estimate the rate of detection and incidence of talimogene laherparepvec DNA and virus at the surface of talimogene laherparepvec injection site, the exterior of the occlusive dressing, and the oral mucosa
* To estimate the incidence of talimogene laherparepvec DNA detection in lesions
suspected to be herpetic in origin

The exploratory objectives of the study are to assess blood and tumor tissue for potential biomarkers which predict and/or are correlated with clinical outcomes to talimogene laherparepvec
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071506

A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)

In subjects with first line (1L) stage IV MSI-H or dMMR CRC treated with pembrolizumab(MK-3475) versus Standard of Care chemotherapies, objective: To compare Progression Free Survival (PFS).
Secondaries:To compare Overall Response Rate (ORR) and overall survival(OS)
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