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Carcinoma, Ductal clinical trials

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NCT ID: NCT03319641 Completed - Clinical trials for Adenoid Cystic Carcinoma

PSMA-PET Imaging for Advanced ACC/SDC

Start date: October 25, 2017
Phase: N/A
Study type: Interventional

Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy

NCT ID: NCT03148015 Completed - Breast Cancer Clinical Trials

Novel Molecular Targets for Ductal Carcinoma In Situ (DCIS)

Start date: October 1, 2016
Phase:
Study type: Observational

This project is an immunohistochemical study of archived patient breast tissue, specifically pre-invasive lesion specimens. The purpose is the discovery of novel molecular markers of pre-invasive breast lesions. These novel markers, once validated in this study, can serve as targets for individualized prevention therapy, neoadjuvant therapy for ductal carcinoma in situ (DCIS), or predictors of lesion aggressiveness. We have discovered two novel classes of DCIS molecular pathways required for the survival of DCIS neoplastic cells that will serve as the basis for the candidate molecules to be evaluated in this proposed study. The first class of DCIS molecular markers is autophagy, a cell survival mechanism that we discovered to be highly augmented in the hypoxic and nutrient deprived intraductal neoplastic cells of human DCIS (1-4). The second class of biomarker is calcium efflux that is mediated in breast cells by the calcium export pump Plasma Membrane Calcium ATPase (PMCA2) (5, 6). During normal lactation, breast epithelium pumps large concentrations of calcium into milk. In neoplastic lesions, calcium is exported by PMCA2 as a cell survival mechanism, since cells under metabolic stress accumulate calcium to a toxic level. Calcium export in DCIS may also contribute to intraductal calcifications, a hallmark of high grade DCIS and the most common marker of DCIS on mammography (7). Sentara cares for hundreds of patients per year who are diagnosed with breast pre-invasive lesions, including atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), and lobular carcinoma in situ (LCIS). Sentara treats 25% of the women with breast cancer in Virginia. Coupled with information from the Sentara Cancer Registry, Dr. Hoefer or a research team member will identify eligible patients with ADH, DCIS, and/or LCIS at the time of the core biopsy diagnosis, surgical therapy, and/or upon lesion recurrence. After receiving written informed consent from the eligible patients, Sentara Pathology will retrieve the corresponding tissue blocks. The recut tissue sections will be processed at George Mason University, Center for Applied Proteomics and Molecular Medicine for markers relevant to calcium signaling, Vitamin D response, proliferation, autophagy and inflammation. Combined with the translational research expertise/technology in the Center for Applied Proteomics and Molecular Medicine at George Mason University, Sentara's diverse patient cohort provides an opportunity to address the most fundamental unanswered questions surrounding the etiology, progression, and therapy of pre-invasive breast lesions.

NCT ID: NCT03113825 Completed - Clinical trials for Breast Cancer Female

Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Start date: July 5, 2017
Phase: Phase 2
Study type: Interventional

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

NCT ID: NCT03002766 Completed - Carcinoma Breast Clinical Trials

Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast

DCIS
Start date: March 2000
Phase: Phase 2
Study type: Interventional

By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins. Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.

NCT ID: NCT02908178 Completed - Clinical trials for Ductal Carcinoma In Situ

Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ

Start date: January 25, 2017
Phase:
Study type: Observational

Patients with ductal carcinoma in situ (DCIS) treated with available therapies have experienced excellent outcomes and very low mortality rates due to the disease's non-invasive nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a result, determining strategies to manage DCIS has been identified as a research priority. The role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and needs further scrutiny. Our study addresses this evidence gap as the investigators propose a retrospective cohort study to investigate the outcome of SLNB among DCIS patients. Specifically, the investigators will compare the outcomes, including survival outcomes and treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs. not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims in this study: Aim 1: the investigators select our study sample using SEER-Medicare database. The investigators will determine associations between SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement of upper extremity from the first breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine associations between SLNB and long-term outcomes, including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence, and lasting side effects, from >9 months post-diagnosis to death or the end of this study period. Given the nature of our observational study design, the investigators will apply standard multivariate analyses and propensity score methodology to reduce the influence from confounders. The investigators will control for patient demographics, comorbidities, functional status, tumor characteristics, and prior healthcare utilization. Using distance to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage I/II breast cancer, the investigators also plan to conduct instrument variable analyses if necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis, and tumor size) and their predicted life expectancy (given their age and comorbidities), the investigators also hope to identify patient subgroups who may safely forgo SLNB. The study would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.

NCT ID: NCT02636582 Completed - Clinical trials for Breast Ductal Carcinoma In Situ

Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer

Start date: June 14, 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.

NCT ID: NCT02576106 Completed - Clinical trials for Carcinoma, Ductal, Breast

Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

CRYOSE01
Start date: February 2016
Phase: N/A
Study type: Interventional

The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication. The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells. On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.

NCT ID: NCT02520141 Completed - Cholangiocarcinoma Clinical Trials

Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

Start date: December 29, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT02451553 Completed - Clinical trials for Advanced Malignant Solid Neoplasm

Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer

Start date: November 5, 2015
Phase: Phase 1
Study type: Interventional

This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when given together with capecitabine in treating patients with solid tumors, pancreatic cancer, or biliary cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment and has not responded to previous treatment. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving afatinib dimaleate together with capecitabine may be a better treatment for solid tumors, pancreatic cancer, or biliary cancer.

NCT ID: NCT02392637 Completed - Clinical trials for Unresectable Gallbladder Carcinoma

Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers

Start date: April 2, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver) that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells.