Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC) + save

Date Added
August 19th, 2014
PRO Number
Pro00019998
Researcher
Virginia Herrmann
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for patients with multiple ipsilateral breast cancers (MIBC). The purpose of this research study is to see if removing only the tissues from the 2 or 3 cancers in the patient's breast (breast conservation surgery) in combination with radiation to the breast, instead of removing the patient's entire breast (mastectomy) is safe in keeping the patient's cancer from coming back in the patient's breast. Patients will be asked to visit the study doctor for follow-up exams for up to 5 years after patients have completed WBI.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

Cervical Cancer Screening Among Lesbian and Bisexual Women + save

Date Added
August 15th, 2014
PRO Number
Pro00036905
Researcher
Michael Johnson
Keywords
Cancer, Cancer/Gynecological, Non-interventional, Obstetrics and Gynecology, Women's Health
Summary

Lesbian and bisexual women under utilize cervical cancer screening programs as compared to heterosexual women. This study uses interviews to explore, identify, and examine the factors that influence cervical cancer screening participation among lesbian and bisexual women. The findings from this study will generate new knowledge and enhance understanding of the cervical cancer screening among lesbian and bisexual women. The findings from this study can be used to design specific interventions to improve cervical cancer screening among lesbian and bisexual women.

Institution
MUSC
Recruitment Contact
Michael Johnson
702-301-1874
johnsmj@musc.edu

A Multi-Arm Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Dual PI3K/mTOR Inhibitors PF-04691502 and PF-05212384 in Combination with Experimental or Approved Anticancer Agents in Patients with Advanced Cancer. + save

Date Added
August 12th, 2014
PRO Number
Pro00028355
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult males and females who have been diagnosed with cancer. This study involves a new investigational drug called PF-05212384 that is currently not FDA-approved for sale in this country. The first goal of this study is to determine the highest dose of PF-05212384 that can be tolerated without endangering the patients (MTD). When the MTD is found, additional patients will be enrolled to the study to examine the safety and tolerability of PF-05212384 in combination with other study drugs. Each participant will receive only one of the two possible combinations described below of study drugs while in this study. Patients may be in this study for approximately up to 1 year. Depending on the treatment he/she is given, he/she may need to visit the clinic daily, after the initial dose period. The visits to the clinic may then be as much as every 4-6 days during the first 6 “cycles” (each cycle is approximately 28 days) of treatment.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A Multi-Center, Open-Label, Single-Arm, Phase 2 Study of ASONEP™ (Sonepcizumab/LT1009) Administered as a Single Agent to Subjects with Refractory Renal Cell Carcinoma + save

Date Added
August 12th, 2014
PRO Number
Pro00021213
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for subjects diagnosed with a type of kidney cancer called renal cell carcinoma or renal cell cancer whose disease has worsened despite having received treatment with a VEGF inhibitor and/or mTOR inhibitor. This research study is a way of obtaining more information about how to treat renal cell cancer with a new drug called ASONEP. The purpose of this Phase 2 research study is to evaluate the safety and effectiveness (how ASONEP could treat cancer) of ASONEP following weekly injections (infusions). To qualify to participate in the study, subjects must first have some medical tests and interviews with the study doctor and study staff. If eligible, subjects will be enrolled in this study for at least 2 months. If ASONEP is safe for subjects and it is in their best interest to continue receiving it as determined by the study doctor, they can continue on the study after 2 months.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Physician Order for Scope of Treatment (POST): PILOT STUDY + save

Date Added
August 4th, 2014
PRO Number
Pro00022252
Researcher
Walter Limehouse
Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a “DNR” or “Allow Natural Death” order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient’s treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu

PROSPECTIVE PHASE III EVALUATION OF FETAL FIBRONECTIN IN A HIGH RISK ASYMPTOMATIC POPULATION FOR THE PREDICTION OF SPONTANEOUS PRETERM BIRTH + save

Date Added
July 22nd, 2014
PRO Number
Pro00026710
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Fetal fibronectin (also known as fFN) is a “glue-like” protein that bonds your developing baby to your uterus. Fetal fibronectin is detectable in vaginal secretions in the very beginning of pregnancy, when this bond is first forming, and then again at the end of pregnancy, when your body is getting ready to deliver your baby.

fFN is a special protein that literally holds your baby in place in the womb. After the 35th week of pregnancy, it begins to break down naturally, and is detectable. If your body is getting ready to give birth prematurely, fFN may be detected before week 35.

Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy.

The goal of the study is to evaluate the benefits of collecting fFN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843.792.6323
yeadon@musc.edu

FLT3 Mutation Diagnostic Assay Development Study + save

Date Added
July 22nd, 2014
PRO Number
Pro00019884
Researcher
Robert Stuart
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to extract DNA from blood and/or bone marrow so that genetic information can be used to study whether the participants response to treatment with midostaurin and any side effects that they may have developed are related to the participants genes. Pharmacogenetics looks at how genes influence the different responses that people have to the same drug. Genes contain the instructions for making all living things and are contained in DNA. Most DNA is the same among human beings, but the small variations we all have in our DNA causes differences in people, such as different sizes and hair color. These kinds of differences may also explain why different people have different responses to the same drug.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Validating simulation and evaluation tools for the management of shoulder dystocia protocols in physician evaluation and education at the Medical University of South Carolina. + save

Date Added
July 16th, 2014
PRO Number
Pro00026863
Researcher
Christopher Goodier
Keywords
Obstetrics and Gynecology, Women's Health
Summary

Shoulders dystocia (SD) is an obstetric emergency resulting from a discrepancy in size between the fetal shoulders and maternal pelvic inlet, resulting in impaction of the fetal shoulder(s) against maternal pelvic bone(s) following delivery of the fetal head.

Obstetric providers need to be adequately trained to manage this emergency effectively. Traditionally, trainees are taught how to perform these maneuvers with lectures/articles describing maneuvers with pictorial representations. There is no currently accepted “best practice” regarding which sequence of alleviating maneuvers is preferred to resolve a shoulder dystocia.

What is needed is an effective method to train providers for management of shoulder dystocia. Additionally, there are tools needed to assess the competency of providers in the management of shoulder dystocia. Theoretically, stimulation training could fulfill both of these roles. This study will assess the simulation of shoulder dystocia during vaginal delivery.

Institution
MUSC
Recruitment Contact
Amanda Sibai
843.792.6654
sibai@musc.edu

An open-label phase II study of BKM120 in patients with relapsed and refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma + save

Date Added
July 14th, 2014
PRO Number
Pro00024660
Researcher
Alice Mims
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to learn if the study drug BKM120 can slow the progression of cancers found in the lymph nodes, including diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma, which have worsened despite treatment.The potential harmful effects of BKM120 will also be studied. The subjects functional status, symptoms, the changes in the size of tumors and laboratory results obtained while the subject is receiving the study drug will help the research team to determine if BKM120 is safe and effective in subjects.
BKM120 is a medicine that is being developed for the treatment of different tumor types. It has not been approved yet by the health authorities, for example FDA in US or EMEA for the European Union. The medicine being tested in this study is currently not “on the market” (available for purchase) in any country. So far, approximately 250 patients with different types of tumors have received BKM120, either alone or in combination with another anti-cancer drug in other studies.

Institution
MUSC
Recruitment Contact
Jennifer Clarke
843-792-9579
clarkejh@musc.edu

Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma + save

Date Added
July 14th, 2014
PRO Number
Pro00019706
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This is a study for subjects with transitional cell carcinoma. Transitional cell carcinoma (TCC) is a type of cancer that is usually from the bladder, but can also be from organs associated with the bladder, such as the ureters (tubes connecting the bladder with the kidneys). This research study is evaluating a drug called Everolimus, also known as RAD001, which will be used either alone or with another drug called Paclitaxel as a possible treatment for TCC. Patients with this type of cancer routinely receive Cisplatin-based cancer treatment. However, the study doctor may think that this routine Cisplatin-based cancer treatment will not be good for the patient due to the disease or health condition. After discussing with the study doctor, the patient has the option of participating in this study to receive either Everolimus alone (cohort1) or Everolimus in combination with Paclitaxel (cohort2).
If the patient chooses to take part in cohort 1 of this study, the patient will take Everolimus 10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis. The patient will be provided with an adequate supply of Everolimus for self-administration at home.
If the patient chooses to take part in cohort 2 of this study, the patient will receive Everolimus 10 mg daily orally, as described above, along with Paclitaxel 80mg/m2 given intravenously (in your veins), over one hour on days 1,8 and 15 of a 28-day cycle
The study team would like to keep track of the patient's medical condition for the rest of their life. The study team would like to do this by calling the patient on the telephone once every few months (every 3 months for 2 years from registration for protocol therapy, every 6 months for years 3 - 5 and annually thereafter) to see how the patient is doing. Keeping in touch with the patient and checking the condition helps the study team look at the long-term effects of the research study.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu