Clinical Evaluation of the Actim Partus Test + save

Date Added
May 14th, 2013
PRO Number
Pro00018016
Researcher
Roger Newman
Keywords
Women's Health
Summary

The purpose of this study is to evaluate the ability of an investigational test to predict the risk of preterm or imminent delivery using cervical samples collected with a sterile swab from women less than 36 weeks pregnant and presenting with signs and/or symptoms suggestive of preterm labor and whose fetal membranes are not ruptured. The rapid test is called the Actim PARTUS test. It is an “investigational test”, which means that it is not approved by the U.S. Food and Drug Administration (FDA) and the results from the test cannot be used to assist in making a diagnosis. This study will collect information about the effectiveness of the rapid test to detect in a cervical sample a marker of fetal membrane detachment indicating a high risk of preterm or imminent delivery.

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

A Qualitative Study of the Influence of Trust in the Health Care System on Postpartum Contraceptive Choice + save

Date Added
May 8th, 2013
PRO Number
Pro00023964
Researcher
Angela Dempsey-fanning
Keywords
Obstetrics and Gynecology, Women's Health
Summary

This study will explore women’s views on choosing contraception during the postpartum period in the context of their health care locus of control, trust in their providers and health care system, and reproductive health messages that they received during antenatal and postpartum care. A focus group will be facilitated by a research coordinator during the postpartum period.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-1158
line@musc.edu

A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER + save

Date Added
April 30th, 2013
PRO Number
Pro00024065
Researcher
Melanie Thomas
Keywords
Cancer, Cancer/Gastrointestinal, Men's Health, Women's Health
Summary

This study is for subjects who have cancer of the colon, which has been surgically removed, but has spread to lymph nodes. This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. The Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, researchers will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis and some other painful conditions. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care is 12 treatments with FOLFOX. In this trial, researchers will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. It expected that subjects will be enrolled in this trial for up to 3 years.

Institution
MUSC
Recruitment Contact
Andie Adelman
843-792-1507
adelman@musc.edu

The effects of in utero exposure of antiretroviral therapy on neonate body fat distribution. + save

Date Added
April 25th, 2013
PRO Number
Pro00024418
Researcher
Gweneth Lazenby
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to compare body fat distribution in neonates exposed to antiretroviral (ARV) therapy for the prevention of maternal to child transmission (MTCT) of HIV versus ARV naive neonates born at a similar gestational age to HIV-negative women. As a secondary analysis, we will examine the differences in body fat distribution among ARV-exposed neonates comparing PI-exposed versus non-PI exposed.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843-792-6323
yeadon@musc.edu

A Phase II, Open-labeled, randomized study of MEHD-7945A vs. Cetuximab in Patients with recurrent/metastatic squamous cell carcinoma of the Head and Neck who have progressed during or following platinum-based chemotherapy + save

Date Added
April 22nd, 2013
PRO Number
Pro00016993
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Minorities, Women's Health
Summary

The main purpose of this study is to find out what effects, good and/or bad, MEHD7945A has on you and your cancer. In this study there will be two treatment arms. You will be treated with either MEHD7945A or cetuximab, a drug that is commonly used for your type of cancer. You will not be treated with both drugs at the same time.

Institution
MUSC
Recruitment Contact
Adam Fiebelkorn
843-792-6349
fiebelko@musc.edu

A Prospective, Longitudinal Study Of YKL-40 In Patients With FIGO Stage III Or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy + save

Date Added
April 18th, 2013
PRO Number
Pro00018015
Researcher
David Griffin
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate a new test that measures YKL-40 to see if the amount of YKL-40 in the blood can help monitor ovarian, fallopian, or primary peritoneal cancer.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Prospective Collection of Female First-catch Urine, Vaginal Swab, Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays + save

Date Added
April 9th, 2013
PRO Number
Pro00023016
Researcher
Gweneth Lazenby
Keywords
Obstetrics and Gynecology, Women's Health
Summary

The purpose of this research study is to obtain several specimens or samples from study participants. The specimens collected are the same samples collected during a standard visit to your doctor. These samples include urine and swabs from your vagina. These samples will be tested for diseases that are passed through sexual contact. These common diseases include gonorrhea, chlamydia, and trichomonas.

The samples will be tested on instruments designed to test for sexually transmitted diseases (STDs). The data generated from testing these samples will be submitted to the Food and Drug Administration (FDA) to support the use of tests developed by the Gen-Probe, Inc. These name of these tests or assays are: 1) APTIMA COMBO 2 Assay and 2) APTIMA Trichomonas vaginalis Assay. These assays will be tested on instrument known as: 1) the PANTHER System and 2) the TIGRIS System.

By testing the samples using the APTIMA assays on these instruments this will help lead to increased detection and treatment of STDs.

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

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF VTX 2337 (IND # 78, 416) IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN PATIENTS WITH RECURRENT OR PERSISTENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER + save

Date Added
March 26th, 2013
PRO Number
Pro00022783
Researcher
William Creasman
Keywords
Cancer, Cancer/Gynecological, Women's Health
Summary

This study is for subjects with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after treatment or did not respond to earlier treatment. The purpose of this study is to compare pegylated liposomal doxorubicin (PLD; a standard chemotherapy) to PLD in combination with VTX-2337 (a new type of drug that stimulates the immune system) to see if it helps cancer tumors stop growing or shrink, and if it helps women with these types of cancer live longer. PLD is an FDA-approved treatment for women with ovarian cancer. In prior studies, approximately 15–20% of women who received PLD for relapsed ovarian cancer experienced a temporary shrinkage or disappearance of their tumor. VTX 2337 is an experimental drug (not approved by the Food and Drug Administration, FDA) that stimulates the immune system and may help the body kill cancer cells. The combination of PLD plus VTX-2337 has been evaluated in a previous study of 13 patients. The study is still ongoing, but so far there is evidence that PLD + VTX-2337 may temporarily stop some patients’ tumors from growing (this happened in 6 patients), or it may help cancer tumors temporarily shrink and/or disappear (this happened in 1 patient).
In addition to the treatment part of this study, the researchers plan to test samples of your tumor and some of your blood. You cannot participate in this study if you do not agree to provide these specimens for this research. The purpose of this research is to examine the impact the study drugs have on tumor tissue and specific blood cells and substances.
Lastly, researchers want to know if one's genes (DNA) affect how the body responds to the experimental medication or how one's body breaks it down. Subjects will receive the study drugs as long as there is evidence that their tumor is not growing and they are not experiencing unacceptable side effects.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

Specimen Collection from Pregnant Women at Increased Risk for Fetal Chromosomal Aneuploidy for use in Development of a Noninvasive Fetal Aneuploidy Test + save

Date Added
March 26th, 2013
PRO Number
Pro00010416
Researcher
Charles Rittenberg
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This is a multicenter, observational study.
This research study will test whether the methods being developed for the detection of fetal aneuploidy from samples of maternal blood can be used in the laboratory and employed in clinical practice

Institution
MUSC
Recruitment Contact
Betty Oswald
843 792 0347
oswaldbw@musc.edu

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. + save

Date Added
March 25th, 2013
PRO Number
Pro00023965
Researcher
Whitney Graybill
Keywords
Cancer, Cancer/Gynecological, Women's Health
Summary

This study is for subjects with ovarian, fallopian tube or peritoneal primary cancer that has come back after original treatment. In this study, subjects will be able to choose whether or not to receive bevacizumab with paclitaxel and carboplatin or gemcitabine and carboplatin treatment. If subjects elect to receive bevacizumab, they will receive it every three weeks beginning with the second cycle of therapy and will continue to receive bevacizumab alone after therapy every three weeks as long as there is no evidence that their tumor is growing or that they are experiencing unacceptable side effects.
The primary purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that subjects remain disease free. If subjects' doctors feel that they are a good candidate for the second surgery they will be randomized to have surgery or not. A computer program will place subjects in one of the study groups. Neither subjects nor the doctor can choose the group they will be in. If subjects are randomized to receive the surgery it will be performed before chemotherapy is given. Chemotherapy will not be given until subjects recover from the surgery which could take up to six weeks.
Another purpose of this study is to test samples of subjects' blood, some of their tumor if left over from a previous surgery, and some of their tumor and normal tissue if left over from surgery performed as part of this study. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.
Subjects will receive chemotherapy treatment as long as there is evidence that they are benefiting from the therapy and are not experiencing unacceptable side effects up to a total of 8 treatments. If they choose to receive bevacizumab, subjects will receive this therapy in combination with chemotherapy. If subjects appear to be benefiting from treatment and have reached a maximum of 8 cycles of chemotherapy, they will receive bevacizumab as long as there is evidence that they are benefiting from the therapy and are not experiencing unacceptable side effects. Subjects will be followed by the study doctor for the rest of their lives. Subjects can withdraw from the study at any time.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu