Newsletter Featuring research studies conducted by the

Center for Women’s Reproductive Health/OBGYN Department

TheSpotlight@uabmc.eduEmail us at: October 2019

Congratulations to Dr. Richter (UroGyn), who was featured in the UAB SOM News for her publications in the Journal of American Medical Association. She recently co-authored two

studies: SUPeR: Study of Uterine Prolapse Procedures and ESTEEM: Effects of Surgical Treatment Enhanced with Exercise for Mixed urinary incontinence. https://www.uab.edu/news/people/item/10782-richter-co-writes-two-studies-in-the-journal-of-the-american-medical-association

Breast Cancer

Awareness

Month

Congratulations to Dr. Leath (Gyn/Onc) for his work on the VELIA study. This data was presented recently at the European Society for Medical Oncology conference

and published concurrently in the New England Journal of Medicine. A copy of the press publication may be found here: https://www.nejm.org/doi/full/10.1056/NEJMoa1909707?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed

A special recognition goes to Gerrie Franklin, Director Clinical Operations, for outstanding research support! Besides making sure that all OB patients have the best clinical experience, she actively promotes research participation by helping overcome barriers that often hinder research participation.

Getting her clinical team involved in reminder calls to ultrasound patients scheduled for anatomy scans, so that they come to their appointment prepared for the transvaginal u/s CL screening, which is now part of routine prenatal care. She has been instrumental (together with the ultrasound team) in improving the CL screening rate during anatomy ultrasounds. As research and clinical care teams increasingly work as one team, she has been instrumental in making sure research clinical space is in compliance with all regulations. Additionally, Gerrie has helped organize and re-purpose research clinical space so that it has become functional and suited for daily use for employees and patients. When asked about her thoughts on research, she simply said, “research is what drives improvements in care! I do believe it is the path for bridging the gap between existing health care and ideal health care.”Gerrie Franklin, a true champion for…

One Team… One Mission!

Investigator / Sponsor: Alan Thevenet N. Tita (Columbia University)Project Title: Vaginal Progesterone Versus 17-OHPC for Recurrent Preterm Delivery: A Randomized Clinical Trial Investigator / Sponsor: John Owen (EMMES CORPORATION)Project Title: Ambient Air Pollution Exposure During Pregnancy and Longitudinal Fetal Growth

Investigator / Sponsor: Akila Subramaniam (University of Maryland)Project Title: Assessment of Azithromycin Impact to Optimize Future Program Design in Mali

Investigator / Sponsor: Rebecca Arend (GOG FOUNDATION INC.)Project Title: GOG Foundation Scholar Investigator Award

Investigator / Sponsor: Ashley Nicole Battarbee (University of North Carolina)Project Title: Fetal Metabolic Consequences of Late Preterm Steroid Exposure

Investigator / Sponsor: Janeen L. Arbuckle (LUPIN INC.)Project Title: A Multi-Center, Open-Label Study to Evaluate the Safety of a Single Oral Dose of SolosecT (secnidazole) 2g Oral Granules for the Treatment of Adolescent Girls with Bacterial Vaginosis

Investigator / Sponsor: Rebecca Arend (NATIONAL COMPREHENSIVE CANCER NETWORK)Project Title: The Role of TGF-B in Immune Suppression in Suboptimally Debulked Ovarian Cancer Patients

Investigator / Sponsor: Akila Subramaniam (NIH - National Institutes of Health/DHHS)Project Title: Childhood Follow-Up Study of Obesity and Neurodevelopment After Perinatal Exposure to Adjunctive Azithromycin Prophylaxis for Cesarean Delivery

Investigator / Sponsor: Lorie M. Harper (NIH - National Institutes of Health/DHHS)Project Title: A Novel Antenatal Test to Distinguish Gestational Diabetes from Type 2 Diabetes and Predict Future Adverse Outcomes

Investigator / Sponsor: Akila Subramaniam (University of North Carolina at Chapel Hill)Project Title: The Pharmacoepigenomics of Recurrent Preterm Birth Non-Hispanic Black Women

Investigator / Sponsor: Janeen L. Arbuckle (ABBVIE INC)Project Title: A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women

Investigator / Sponsor: Rachel Sinkey (GESTVISION, INC.)Project Title: Clinical Evaluation of the GestAssuredTM Test Kit

Investigator / Sponsor: Rebecca Arend (NATIONAL COMPREHENSIVE CANCER NETWORK)Project Title: The Role of TGF-B in Immune Suppression in Suboptimally Debulked Ovarian Cancer Patients

Grant Awards July through September 2019

Grant Submissions July through September 2019

Congratulations to the entire ultrasound team on a very successful September. They had a 90% consent rate for cervical length screening. This CL screening is usually obtained during OB anatomy scans. This increase in screening helped our research team identify more patients with short CL’s which is the major qualification for the MFMU network TOPS (singleton pregnancy) & Prospect (twin pregnancy) studies.

mailto:thespotlight@uabmc.eduhttps://www.uab.edu/news/people/item/10782-richter-co-writes-two-studies-in-the-journal-of-the-american-medical-association https://www.uab.edu/news/people/item/10782-richter-co-writes-two-studies-in-the-journal-of-the-american-medical-association https://www.uab.edu/news/people/item/10782-richter-co-writes-two-studies-in-the-journal-of-the-american-medical-association https://www.uab.edu/news/people/item/10782-richter-co-writes-two-studies-in-the-journal-of-the-american-medical-association https://www.nejm.org/doi/full/10.1056/NEJMoa1909707?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmedhttps://www.nejm.org/doi/full/10.1056/NEJMoa1909707?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmedhttps://www.nejm.org/doi/full/10.1056/NEJMoa1909707?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmedhttps://www.nejm.org/doi/full/10.1056/NEJMoa1909707?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed

One Team, One MissionWe are all one and connected and here to serve our patients, no matter where we work,

which division, which physical location, or whether clinical or research.

Fall Fling Team Gail Williams, Jenny Walton, Gerrie Franklin, Monica Stuart, Jan Grant, Tawanda Hill, Nicolle Burrell, Linda Rowe

Pam Hicks, Tunya Scott, Lakia Sparks -Pam Files (t-shirts production) -Nikesha Fantroy & Stacy Harris, Photographers

BIOBANKS/TISSUE STUDIES, etc.

As part of the Division of GYN Oncology, our Biobanks are housed in the Arend lab – our goal is to bank tissue and blood for patients with ovarian cancer, carcinosarcomas, and cervical cancer.

GYN ONC OPEN TRIALS

GOG279 – Phase II trial with treatment of radiation therapy, cisplatin, and gemcitabine hydrochloride in patients with locally advanced squamous cell carcinoma of the vulva. Includes surgical evaluation of lymph nodes.

Vulvar Cancer

Exemestane study UAB1788– Window of opportunity study with treatment of Exemestane for 3 weeks prior to hysterectomy in patients with CAH or G1/2 endometrioid endometrial adenocarcinoma.

CAH OR G1/G2 Endometrial Cancer

NRG GY017 – Phase I trial with treatment of Atezolizumab before and/or with chemoradiotherapy in patients with PA node positive stage IB2, II, IIIB, or IVA primary cervical cancer.NRG GY006 – Phase III trial with treatment of radiation therapy with cisplatin alone or in combination with Triapine in women with stage IB2, II, IIIB, or IVA primary cervical cancer or stage II-IVA vaginal cancer.UAB1544 – Pilot study with treatment of the TA-CIN vaccine in patients who have undergone definitive therapy for cervical cancer in the past 12 months.

Cervical Cancer

UAB1753 – Phase III trial with treatment of metformin in conjunction with chemotherapy followed by metformin maintenance therapy in advanced stage ovarian, fallopian tube, and primary peritoneal cancer in the adjuvant or neoadjuvant setting.OVATION2 study UAB1839– Phase Ib/II trial with treatment of GEN-1 in the neoadjuvant setting for advanced stage ovarian, fallopian tube, and primary peritoneal cancer.NRG GY005 – Phase II/III trial with treatment of Cedaranib v. Cedi/Olaparib v. non-platinum chemotherapy in patients with recurrent platinum resistant or refractory high grade serous or endometrioid ovarian cancer (other histologies may receive if they have a documented germline BRCA mutation).

Ovarian Cancer

IMPROVE - A study for post menopausal woman who is not currently using estrogen as a medication or has chosen to stop your current estrogen therapy for a period of 1 month and is planning surgery to repair pelvic organ prolapse.PI: Holly RichterInclusion:- Vaginal bulge by exam with bothersome symptoms.- 48 years of age or older and have transitioned through menopause (or have had ovaries surgically removed in the past)- Willing to randomize to use/apply estrogen cream or a look-alike inactive cream (placebo) for about 6 wks before surgery and then for the first year after their surgery- Patients who desire surgical treatment for prolapse

POWeR - A study is for Post menopausal women (ages ≥ 55 years) with or without UI Undergoing an osteoporosis evaluation (DXA and TBS) PI: Isuzu MeyerInclusion: - Female age 55 or older who has not had a DEXA scan in the past 10 years.

UroGyn Studies at TKC & WICFor more info, please leave a message at: 205-934-5498 or email us at: urogynecology@uabmc.edu

Allergan - A study for women with refractory urgency urinary incontinence. This is a Phase 2 randomized dose finding trial where either placebo, 100U, 200U, 300U or 500U botox are mixed in a hydrogel and instilled into the bladder with a catheter in the office.PI: Holly RichterInclusion:-Ages 18-75-Symptoms of overactive bladder including frequency, urgency and urgency urinary incontinence-Previously tried medications and had inadequate response or intolerable side effects-Weight ≥40 kg (88 pounds)

Renovia 17-Fl - A NON-INVASIVE (IN-HOME EXERCISES) study for fecal incontinence (FI). Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment.PI: Holly RichterInclusion:- Patients with fecal incontinence or bowel leakage- Female and 18 years of age and olderIMPLORE - Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy in postmenopausal women with vulvovaginal atrophyPI: Kyle NorrisInclusion:- Age ≥55 years old and a screening vaginal pH of ≥5. - Without menses for ≥12 months. - No uterovaginal or vaginal vault prolapse beyond the hymen.

UAB1824 – Phase I trial with treatment of SY-1365 (a CDK7 inhibitor) in patients with recurrent platinum sensitive or resistant ovarian cancer. If the histology is not clear cell, carboplatin is added to the regimen.

PUMA study UAB1839– Phase II trial with treatment of Neratinib in patients with recurrent ovarian or cervical cancer with documented ERBB2/3/4 mutations or EGFR amplifications.

UAB1861 – Phase Ib/II trial with treatment of Rebastinib (TIE2 inhibitor) in combination with paclitaxel in patients with recurrent ovarian cancer or recurrent/metastatic/high risk endometrial cancer.

UAB17105 – Phase II trial with treatment of DKN-01 (a WNT modulator) +/- weekly paclitaxel in patients with recurrent ovarian or uterine carcinosarcoma.

GARNET – UAB1659- Phase I trial with treatment of TSR-042 in patients with recurrent MSI-H cancers (endometrial, ovarian, cervix, sarcomas). Cannot enroll until October with the allowance for slide submission is amended. Current requirement is blocks.

Other

DETECT – A study for women undergoing hysterectomy for reasons other than ovarian or cervical cancer where a tampon is placed preoperatively to evaluate for the presence of endometrial cancer in the tampons.

@UAB_CWRHFollow us on Twitter

For more info, please leave a message at: 205-934-6454 or email Anna Wilbanks, MSN, RN, WHNP-BC asb2013@uab.edu

UAB Center for Clinical and Translational Science (CCTS): The CCTS is a major national initiative that aims to catalyze the translation of fundamental and clinical research into improvements for human health and health care delivery. By developing a diverse, well-trained workforce in translational science, by promoting an efficient scientific infrastructure, by engaging our communities in partnership to identify challenges and create approaches to solutions, and by assuring effective use of available resources, the CCTS Partner Network accelerates the pace of discovery to delivery across the entire translational spectrum. We encourage all faculty, trainees and staff to bookmark the CCTS website – there is something for everyone! Free resources include: Funding Opportunities, Grant Review Panels, Drop-in clinics (Stats/Epi), Grant Samples Library, Protocol Development, Regulatory Support, Academic Writing, Avoiding Burnout, UAB Promotion and Tenure, Mentoring, etc. https://www.uab.edu/ccts/

mailto:urogynecology@uabmc.eduhttps://twitter.com/@UAB_CWRHmailto:asb2013@uab.edu https://www.uab.edu/ccts/

For more info, please contact us at: MFMResearchRecruit@uabmc.edu

Inclusion: - 18-45- Singleton- 10-20.6 weeks

- On insulin or willing to start- Willing to stop their oral agent and be on ours

MOMPOD-Medical Optimization & Mgmt of Preg. w/Overt Type II Diabetes PI: Lorie Harper

Inclusion: - Singleton pregnancy- GA 16.0-23.6 wks

- CL on TVUS 20.0mm or less- No h/o spontaneous PTB

TOPS - RCT of Pessary in Singleton Pregnancies with a Short Cervix PI: Lorie Harper

Inclusion: - Twin gestation - GA 16.0-23.6 wks - CL on TVUS or=500, C/S >or= 100-1500, with failed 1st line uterotonic & massage

LIGASSURE - Compare the technical feasibility and surgical outcomes between complete salpingectomy performed with Ligasure vs previously performed during the SCORE trialPI: Akila SubramaniamInclusion: ≥ 25, OBCC patients desiring permanent sterilization & undergoing c/sectionHPV - Exploratory study-rates of vaccination uptake in Postpartum patientsPI: Haller SmithInclusion: 16-26 y/o, postpartum day 1-4, vaginal or c/s, received PNC at OBCC or a Jefferson County HDMicrobiology Cord Blood - Investigating the way the environment affects certain immune cells, called B cellsPI: Rodney KingInclusion: 19 or older, > or=37 weeks GA, English speakingE-ALPS-(coming soon) - RCT (maternal blood glucose screening with treatment of hyperglycemia with insulin vs usual care with no CBG screening or treatment) to determine if keeping mom’s blood sugar normal during labor will help to prevent the baby from developing low blood sugar after birth.PI: Ashley Battarbee Inclusion: singleton pregnant women who received 1st dose of BMZ at 34.0 to 36.5 GA or who have already received BMZ within 6 hours of randomization, expected preterm delivery by any of following: ROM, PTL, maternal or fetal indications. Delivery expected in no less than 12 hours and no more than 7 days.

Sickle Cell Study - Maternal/cord blood collection studyPI: Akila SubramaniamInclusion: 14 or older with at least one S gene. AS, ASF, SCF, SFA, SS

SAVVY- Pfizer RSV vaccine study- coming soonPI: Dr. Alan TitaInclusion: - Women 18-49 y/o with an uncomplicated singleton pregnancy - 24.0 to 36.0 weeks gestation at time of vaccineRecruitment ends 10-31-2019

• 2 or more major congenital anomalies• 1 major and 2+ minor anomalies• 1 major anomaly & unexplained major medical condition

• 1 major anomaly & 1st degree rel w/ same anomaly• OR suspicion of a potential underlying genetic condition

SouthSeq: Whole Genome Sequencing (WGS) for 1500 live-born infants with multiple congenital anomalies. Clinical trial arm will compare return of WGS results by non-genetics providers vs genetics providers, in order to facilitate deliberative process to develop guidelines for future implementation of WGS testing in neonates. Patients may be approached during prenatal visits or immediate postpartum period.PI: Akila SubramaniamInclusion:

mailto:MFMResearchRecruit%40uabmc.edu?subject=