PH IRB #2012-061; Pro00017643: Lung Cancer Surgery: Decisions Against Life Saving Care – The Intervention. Save

Date Added
May 18th, 2015
PRO Number
Pro00017643
Researcher
Maria del mar Cirino-marcano
Keywords
Cancer, Cancer/Lung, Ethnicity and Disease, Men's Health, Minorities, Pulmonary, Stage I, Stage II, Surgery, Women's Health
Summary

Lung cancer is the leading cause of cancer death with a higher mortality rate among African Americans. For patients that have stage I or II non-small cell cancer, surgery is the only curative treatment. In a previous study we conducted, we found that African Americans were less likely to have surgery than other groups. The purpose of this study is to find out what patients understand about their medical condition, what can be done to get the very best lung cancer surgery treatment, and how we can close the treatment gap.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
803-799-5022
alisha.henderson@uscmed.sc.edu

A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Comination with OGX-427 in Patients with Relapsed or Refractory Metastatic Urothelial Carcinoma after Receiving Platinum-containing Regimen Save

Date Added
May 12th, 2015
PRO Number
Pro00026419
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

This study is for subjects who have inoperable (surgical treatment is not an option) or metastatic (has spread to other parts of the body) urothelial carcinoma (includes cancer of the bladder, urethra, ureter or renal pelvis) and who are not responding to platinum-based chemotherapy (such as carboplatin or cisplatin).
This study will evaluate whether treatment with OGX-427 in combination with docetaxel can prolong survival time compared to treatment with docetaxel alone in patients with urothelial carcinoma (UC) who are no longer responding to treatment with a platinum-based chemotherapy regimen. Docetaxel (also known as Taxotere®) is commercially available and is approved by the Food and Drug Administration (FDA) in the United States for the treatment of breast, stomach, lung, prostate and head and neck cancers. OGX-427 is a new drug that is experimental (not approved by the FDA).
The use of docetaxel in combination with the experimental drug OGX 427 in this study is investigational. “Investigational” means that the combination of drugs is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved this combination of drugs.
Subjects in Group A will receive 9 days of loading doses, 10 cycles of combined treatment at 3 weeks per cycle, and maintenance treatment with OGX-427 only until the disease progresses or they experience unacceptable side effects.
Subjects in Group B will receive 10 cycles of docetaxel alone at 3 weeks per cycle, for a total of about 30 weeks. Everyone who completes study treatment with no evidence of disease progression will be followed every 6 weeks until disease progression. Everyone will be followed every 3 months after disease progression for survival.

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

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies Save

Date Added
May 12th, 2015
PRO Number
Pro00034909
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

AZD5363 is a new anti-cancer treatment being developed by AstraZeneca that has not yet been approved for use. This study is part of a research project for collecting information about the safety and effectiveness of this treatment for the first time. The main purpose of the study is to establish a safe dose of the drug by gathering information on how well it is tolerated, any potential side effects it may cause and collecting data about how your cancer responds to the drug. The study will also measure the levels of AZD5363 in the blood and the action of AZD5363 in the body over a period of time. It will also indicate whether the drug has an effect on the type of cancer that the subjects have.

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

A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women Save

Date Added
May 7th, 2015
PRO Number
Pro00030938
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

An Open-Label Phase I Dose-Escalation Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Maximum Tolerated Dose Of BAY 1143572 Given In A Once-Daily Or An Intermittent Dosing Schedule In Subjects With Advanced Malignancies Save

Date Added
April 28th, 2015
PRO Number
Pro00043216
Researcher
Carolyn Britten
Keywords
Cancer, Cancer/Breast, Men's Health, Stomach, Women's Health
Summary

This research study examines the investigational study drug, BAY 1143572 because it is believed the drug may have an effect on the growth of cancer. This study is enrolling people who have been diagnosed with diffuse large B-cell lymphoma (DLBCL), gastric (stomach) cancer or triple negative breast cancer.
The purpose of the study is to evaluate the safety, tolerability and maximum tolerated dose of BAY 1143572. This study is considered research because the study drug BAY 1143572 is investigational (experimental) and has not been approved by the U.S. Food and Drug Administration (FDA) for sale yet. this drug has not been tested in humans. The amount of time participants can expect to be in this study depends on well he or she responds to the treatment.

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

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder Save

Date Added
April 28th, 2015
PRO Number
Pro00034068
Researcher
Steven Swift
Keywords
Obstetrics and Gynecology, Women's Health
Summary

The purpose of this study is to examine how well tolerated and how effective two medicines given together (solifenacin succinate and mirabegron) are in the treatment of your bladder problems over a 54-week period. Both these medications have already been shown to be effective in treating OAB if given separately.

Institution
MUSC
Recruitment Contact
Betty Oswald
843.792.0347
oswaldbw@musc.edu

An open-label Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY 1143572 given in a once-daily or an intermittent dosing schedule in subjects with advanced acute leukemia Save

Date Added
April 28th, 2015
PRO Number
Pro00042265
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with acute leukemia. The investigational drug in this study is BAY 1143572. The purpose of the study is to evaluate the safety, tolerability (the effect of the drug on your body), pharmacokinetics (the effect of your body on the drug) and maximum tolerated dose of BAY 1143572 when given to subjects with acute leukemia who have tried all available treatments. Participants can expect to be in this study until disease progression, unacceptable side effects, withdraw of the consent to participate in this study (you decide to no longer take part in the study), or doctor decides that stopping your treatment is in your best interest.

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

A211102, Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention versus Placebo Control in Premenopausal Women Save

Date Added
April 21st, 2015
PRO Number
Pro00043305
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for females, ages 25-55, who have tested positive for atypia (early cell changes that are thought to be a marker of breast cancer risk) in the breast, and are considered high risk for the development of breast cancer in the future.

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (marker of breast cancer risk) in women at increased risk for breast cancer. This study will test for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study sponsor would like to compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. In this study, patients will get either metformin or a placebo (an inactive product) for the first twelve months. After the first twelve months, women who received placebo during the first twelve months can choose to receive metformin for the second year.

Note: The standard drug used for the “breast cancer prevention” is tamoxifen. If you are eligible to take tamoxifen, you must be offered tamoxifen prevention as part of your clinical care and you must have refused tamoxifen treatment to be on this study. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen.

While on this research study patients will have the Random Periareolar Fine Needle Aspiration (RPFNA) of their breasts to test for atypia (marker of breast cancer risk), before the study starts, and also at 12 and 24 months (24 month optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) after the study starts. If the pathologist does not identify atypia in the samples you will not be able to participate. You will also provide blood during this study to determine if changes in your blood are related to changes in your breasts. You will need to provide a little less than 4 tablespoons of blood for this research study.

Study participation will last for 48 months (2 years).

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

NRG-CC002: PRE-OPERATIVE ASSESSMENT AND POST-OPERATIVE OUTCOMES OF ELDERLY WOMEN WITH GYNECOLOGIC CANCERS Save

Date Added
April 21st, 2015
PRO Number
Pro00043352
Researcher
Jeffrey Elder
Keywords
Aging, Cancer, Cancer/Gynecological, Geriatrics, Surgery, Women's Health
Summary

Participants in this study fall in an older age group and are suspected to have ovarian, fallopian tube, peritoneal or uterine cancer. The usual approach to advanced stage ovarian, fallopian tube, peritoneal or uterine cancer is surgery to remove the cancer and chemotherapy. The surgery could be first in treatment followed by chemotherapy or chemotherapy could be given first to shrink the cancer, possibly followed by surgery and then more chemotherapy. It is sometimes difficult to assess whether a person aged 70 years or older is a good surgical candidate. This study is evaluating a geriatric assessment tool (a questionnaire and some blood work) which would help physicians identify older patients who would do well with surgery. Whether or not patients participate in this study, they will receive treatment and surgery as recommended by thier physician.

Participants will receive the geriatric assessment questionnaire when they are seen by their doctor for consideration of surgery or shortly thereafter. If participants undergo surgery before or after chemotherapy they will be followed for six weeks after surgery to see if they have any complications and what they are. If participants do not have surgery, they will have completed the study once they complete the geriatric assessment questionnaire.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

Assessing the Potential of a Home-Based Prenatal Care Model by Comparing Patient to Provider Measurements Save

Date Added
April 15th, 2015
PRO Number
Pro00030991
Researcher
Krista Wagoner
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to compare routine prenatal measurements taken by patients to the same measurements that are taken by the provider.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-1413
paynej@musc.edu

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