A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 (OFSET)

Date Added
April 2nd, 2024
PRO Number
Pro00134426
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients with invasive breast cancer among premenopausal, early-stage breast cancer with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 and 0-25. The study is being done to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal patients. The drug being used in this study are aromatase inhibitors. Patients will expect to remain in the study for up to 5years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo

Date Added
March 28th, 2024
PRO Number
Pro00135212
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalised vitiligo.
Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
• Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total));
• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).
To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Multi-center, Prospective, Blinded, Randomized study of Artelon FLEXBAND® for patients undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to treat Lateral Ankle Instability

Date Added
March 26th, 2024
PRO Number
Pro00130932
Researcher
Christopher Gross

List of Studies


Keywords
Joint, Pain
Summary

The goal of this randomized controlled trial is to analyze return to pre-injury activity level on subjects with lateral ankle instability undergoing a modified Broström reconstruction procedure for repair of the anterior talofibular ligament (ATFL). The subjects undergoing ATFL reconstructive procedure using the Artelon FLEXBAND® system as an augmentation device will be compared to subjects undergoing a standard modified Broström procedure alone. Artelon FLEXBAND is a commercially available, polycaprolactone (PCL) polyurethane urea (PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. Artelon FLEXBAND has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1 year. All subjects will be followed for 2 years post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 2-, 6-, 12-, 18- and 26-weeks, and 1- and 2-years after surgery. Possible, anticipated procedure-related risks associated with using the FLEXBAND device include, but are not limited to, infections, both deep and superficial, allergies or other reaction to device materials, dislocation, subluxation or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant, bone fractures as a result of one-sided overload or weakened bone structure, temporary or permanent nerve damage as a result of pressure or hematoma, wound hematoma, and delayed wound healing. Benefits include improvement in function, including return to pre-injury activity levels.

Institution
MUSC
Recruitment Contact
Seth Tysor
3362122921
tysor@musc.edu

Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

Date Added
March 25th, 2024
PRO Number
Pro00134487
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.

Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Quantification of Factors Affecting Vaginal Length in Robotic Sacrocolpopexy

Date Added
March 19th, 2024
PRO Number
Pro00134575
Researcher
Faith Dunn

List of Studies

Keywords
Surgery, Women's Health
Summary

The purpose of this study is to better understand how surgical factors affect the length of the vagina after pelvic surgery. This will be accomplished by measuring the length of the vagina during routine surgical steps as well as at the postoperative visit. This information will be used to help continue improving pelvic surgical technique.

Institution
MUSC
Recruitment Contact
Faith Dunn
8437922300
dunnfa@musc.edu

Philips FAST picoSAT convenience sampling for SpO2 accuracy in neonate, infant, and pediatric patients

Date Added
March 19th, 2024
PRO Number
Pro00129656
Researcher
Allison Whalen

List of Studies


Keywords
Children's Health
Summary

The primary purpose of this clinical investigation is to evaluate the SpO2
accuracy of neonatal, infant, and pediatric Philips SpO2 sensors with the Philips
FAST Pulse Oximetry System. Accuracy will be evaluated against the gold
standard, SaO2 obtained from arterial blood samples and assessed by COOximetry.

Additionally, this study will be used to determine if skin pigmentation impacts
SpO2 accuracy and to identify the occurrence of occult hypoxemia, defined as an
SaO2 <88% with an SpO2 ≥92%, with consideration to skin pigmentation.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
8438765403
alsarraf@musc.edu

Comparative Effectiveness of Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure

Date Added
March 5th, 2024
PRO Number
Pro00134707
Researcher
Ronald Acierno

List of Studies

Keywords
Mental Health, Military, Psychiatry
Summary

The purpose of this study is to test the effectiveness of a treatment called Transdiagnostic Behavior Therapy (TBT) for reducing symptoms of adjustment disorder compared to the standard treatment, or treatment as usual (TAU) for adjustment disorder called Moving Forward Problem-Solving Therapy (TAU-PST).

Participants will be randomly selected to receive 10-14 weekly sessions of TBT or TAU-PST with a licensed therapist.

This study is open to Veterans and Active-Duty service personnel in the Ralph H. Johnson VA Health Care System catchment area (including Savannah, Myrtle Beach, Hinesville and Beaufort community-based outpatient clinics).

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Date Added
March 5th, 2024
PRO Number
Pro00134455
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients that have been diagnosed with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III breast cancer. The drug being used Durvalumab, Cyclophospharmide, Doxorubicin, and Paclitaxel. The study is being done to compare breast cancer event-free survival between patients randomized to standard of care neoadjuvant chamotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. Patients are expected to be in the study for XXmonths.

Institution
MUSC
Recruitment Contact
HCC Clincal Trials Office
843-792-9321
hcc-clincial-trials@musc.edu

3D MRA Fusion for Uterine Fibroid Embolization: A Randomized Controlled Trial

Date Added
March 5th, 2024
PRO Number
Pro00133923
Researcher
Marcelo Guimaraes

List of Studies


Keywords
Obstetrics and Gynecology, Women's Health
Summary

The study aims to investigate the impact of Magnetic Resonance Angiography (MRA) fusion on the safety and efficiency of Uterine Fibroid Embolization (UFE). UFE is a medical procedure used to treat uterine fibroids. MRA fusion provides a detailed three-dimensional roadmap of blood vessels in the pelvis during the procedure. This technology has the potential to reduce radiation exposure, procedure time, and contrast volume. .

Institution
MUSC
Recruitment Contact
Derek Groskreutz
8432437260
groskreu@musc.edu

Correlation of photon Counting CT (PCCT) parameters with biomarkers in non-small cell lung cancer (NSCLC) surgical and biopsy specimens.

Date Added
March 5th, 2024
PRO Number
Pro00130202
Researcher
Dhiraj Baruah

List of Studies

Keywords
Cancer/Lung
Summary

The goal of this study is to help compare scans from the new photon counting CT scanner of a solid lung tumor with traditional lab and biopsy results. Subjects enrolled in this study will receive their normal CT scan on the new photon counting CT scanner that has the capacity to provide pictures that are better quality. These images will provide useful information that may lead to future improvements for patients with similar conditions.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu



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