Research studies are designed to advance scientific knowledge while protecting the people who volunteer to participate.
Woman’s Hospital Research Center conducts clinical studies and molecular biology/genetic research, and collaborates with institutions across the world. We follow specific regulations to ensure patients’ safety and privacy.
All research studies are submitted to the Woman's Research and Development Committee. Studies involving human subjects are referred to the Woman's Hospital Foundation Institutional Review Board for review.
The IRB reviews the protocol, consent form, and all other documents for each study. Its main job is to ensure the study participants are protected and that the balance of potential risks and benefits is appropriate. The IRB conducts regular reviews of each active study.
New direction in treatment for women with PCOS
Woman’s is launching a new 24-week study for women who have PCOS and impaired carbohydrate metabolism. The study will test the success of new medicines that have been found to improve abnormal glucose metabolism and reduce body weight.
We are looking for 125 women who meet the following criteria:
- 18-45 years old with PCOS
- Must have a body mass index of 30-45
- Have less than nine periods a year
- Not pregnant or breastfeeding
Participants will be compensated for their time. If you are interested or have questions, please call 225-231-5296.
Study to show if the FDA-approved weight loss drug Saxenda® is effective in reducing body weight and excessive male hormones in obese women with polycystic ovary syndrome (PCOS)
Obesity plays a central role in the development of PCOS, and exacerbates reproductive and metabolic dysfunction. Evidence suggests that medical treatment using drugs that manage obesity may modify the physiological and behavioral processes that contribute to weight gain and impede weight loss.
Saxenda® (Liraglutide 3 mg) is a prescription injectable medicine that is FDA-approved for weight loss. Research has shown that higher doses of drugs like Saxenda® for at least 20 weeks leads to weight loss in obese patients with or without type 2 diabetes. These weight loss effects previously demonstrated offer a unique opportunity to expand the medical options available to obese PCOS patients.
A new study aims to determine how Saxenda® treatment for 32 weeks impacts:
- Body weight
- Free androgen levels
- Menstrual cyclicity
- Glucose regulation
- Insulin sensitivity and secretion
- Body composition
- Cardiometabolic markers (lipids, blood pressure)
To participate in the study, patients must meet the following criteria:
- Age 18-45
- Body Mass Index (BMI) of greater than 30
- Diagnosed with PCOS by hyperandrogenism (elevated male hormone or excess facial hair) and irregular menstrual cyclicity (less than 8 cycles/year)
- Willing to use effective non-hormonal contraception consistently for the study duration
Medication, office visits, lab tests and compensation are provided. For more information on the SAXA PCOS trial, please contact Dr. Karen Elkind-Hirsch or Donna Shaler in Woman’s Research Department at 225-231-5275.
Woman's actively participates in ongoing clinical cancer research.
A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride 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. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients with Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer
CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients with Abnormal Cervical Cells
This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.
A Randomized Phase III trial of Radiation Therapy with or without Chemotherapy in Patients with Stage I or Stage II Cervical Cancer who Previously Underwent Surgery
This randomized phase III trial studies radiation therapy with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
A Phase II Trial Evaluating Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients with Locally Advanced Squamous Cell Cancer of the Vulva
This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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 radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.
To learn about the most recent gynecologic cancer studies, and find out if you are a candidate, please contact Ashley Marks, BSN, RN, 225-924-8215.
The medical staff at Woman's Hospital supports breast cancer clinical trial research
in coordination with Mary Bird Perkins Cancer Center in Baton Rouge.
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation In Breast Cancer Patients (Ct1-3 N1) who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
This randomized phase III trial studies radiation therapy to the breast, chest wall and lymph nodes (comprehensive) compared to standard radiation therapy to the breast in treating patients with early-stage breast cancer previously treated with chemotherapy and surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.
For a complete list of current clinical trials, visit Mary Bird Perkins »
If you are interested in participating in a clinical trial, always contact your physician to discuss options that are available to you. For further information or questions about participation in clinical trials, you may contact a clinical research representative at 225-215-1353, or email us.
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
TRIAL NUMBER: EA1151 TMIST FLYER [PDF] »
Purpose: This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
TMIST is a randomized breast screening trial that will help researchers learn about the best ways to find breast cancer in women who have no symptoms. It compares two Food and Drug Administration (FDA)-approved types of digital mammography: standard digital mammography (2-D) with a newer technology called tomosynthesis mammography (3-D). 2-D mammography takes pictures from two sides of the breast to create a flat image. 3-D mammography images are taken from different angles around the breast and then built into a 3-D-like image. Researchers are doing this trial because they do not know if 3-D is better than 2-D mammography for breast cancer screening.
Another important aspect of the trial is to build a tissue bank for future research. All women who join the trial will be asked to submit tissue samples, such as blood and swabs of cells from inside their mouths. Researchers hope that the information from these tissue samples will help decide the best ways to screen for breast cancer in the future by taking a person’s genetics and other personal risk factors into account.
Who Can Enroll in TMIST:
Women ages 45 to 74 who are planning to get a routine screening mammogram are eligible for this trial.
Physicians: Dr. James Ruiz
Offered in: Baton Rouge (Woman’s Hospital)
For additional information, visit https://www.cancer.gov. To join the TMIST trial call 225-215-1353.