Gynecology Clinical Trials

With groundbreaking studies in minimally invasive surgery and other gynecologic issues, Cedars-Sinai is committed to research that leads to better treatments and healthier lives for women.

Questions? See the Clinical Trials FAQs.

Pending Gynecologic Surgery

Category:

Tissue Bank  

Key Inclusion Criteria:

  • All women must be over the age of 18.
  • Blood and tissue donors:
    • Previously scheduled for gynecologic procedures that involve the removal of all or part of the female reproductive system
  • Follicular Fluid:
    • Patients being seen in the Cedars-Sinai’s OB/GYN–Reproductive Endocrinology Division
  • Blood samples collected only:
    • Patients of the study investigator who are routinely seen for gynecological cancers
  • Saliva samples:
    • Women 18 years or older
    • Seen at Cedars-Sinai for gynecologic evaluation or routine gynecologic care

Summary:

The purpose of the Gynecologic Tissue Bank is to identify genes and/or other markers that influence a woman’s risk of developing cancer or other diseases of the reproductive organs, as well as to discover new tests and treatments for gynecologic cancers and diseases. Researchers also aim to learn how individuals with a particular gynecologic disease will respond to treatments. Blood, tissue and other body fluids will be collected and studied together with clinical and family-history information.

The Gynecologic Tissue Bank will collect materials from individuals who may have cancer or other diseases of the reproductive organs, or individuals who are having gynecologic surgery for benign reasons (healthy controls).

Hereditary Cancer

Condition/Intervention:

Prior genetic testing

Key Inclusion Criteria:

  • Individuals who have undergone genetic testing and have been documented as:
    • Having a known deleterious mutation or
    • A variant of unknown significance or
    • Are wild-type (mutation negative)
  • 18 years of age or older

Summary:

The purpose of this study is to identify factors that influence cancer risk and to better understand the precursors to cancer so that preventive steps can be employed for individuals with and without inherited genetic mutations. Researchers also aim to develop a better understanding about which modifiers (a gene that changes the effect produced by another gene) cause some individuals to be at higher risk for developing cancer.

The study will collect information about personal and family history of cancer, along with personal demographics, medical history, lifestyle habits, and quality of life.

Condition/Intervention:

Surgical menopause

Key Inclusion Criteria:

  • Planning to have surgery to remove both ovaries, or remaining ovary if only one ovary is intact
  • No personal history of ovarian, peritoneal or tubal cancer
  • Menstrual cycles in the past six months or is not yet menopausal
  • Currently has at least one ovary intact

Summary:

The purpose of this study is to identify changes in memory and cognition that may result from surgical menopause in women at high risk of ovarian cancer who choose to reduce their risk of cancer by having their tubes and ovaries removed. The study will examine whether hormone replacement therapy has an effect on memory and cognition.

Researchers will collect information about personal and family history of cancer, along with personal demographics, lifestyle habits and medical history. A cognitive assessment tool will be utilized to better understand individuals at high risk for ovarian cancer.

Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Condition/Intervention:

Ovarian, fallopian tube or primary peritoneal cancer  

Key Inclusion Criteria:

  • Women 18 years of age and older
  • Diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
  • Must have completed all primary chemotherapy and consolidation therapy at least six weeks—and no more than six months and two weeks—prior to enrollment; must be in complete remission

Summary:

The purpose of this study is to evaluate whether a change in diet and exercise in women with ovarian, fallopian tube or primary peritoneal cancer has an effect on the length of time patients are cancer-free following initial treatment. The study also will examine whether the changes in diet and exercise improve overall quality of life and the ability to be physically active.

Half of the participants will follow a diet and physical activity intervention and will receive focused lifestyle coaching. The other participants will continue their usual diet and physical activity and will not be asked to change what they are doing; these women also will receive general lifestyle coaching.

Condition/Intervention:

Ovarian cancer

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • At least 18 years old
  • Diagnosis of recurrent epithelial ovarian, peritoneal or fallopian tube carcinoma that has progressed within six months of prior cytotoxic chemotherapy
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors

Summary:

The purpose of this study is to examine the investigational use of a drug called pembrolizumab in women with recurring ovarian cancer. The study will evaluate the effectiveness and safety of the combination of pembrolizumab with standard-of-care treatment. Pembrolizumab works with the immune system to target tumors. Researchers hope to determine whether pembrolizumab in combination with standard chemotherapy drugs (gemcitabine and cisplatin) is effective in destroying cancer cells.

Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of a type of lung and skin cancer. However, it is not approved by the FDA for the treatment of ovarian cancer.

Condition/Intervention:

Ovarian, fallopian tube or primary peritoneal cancer

Summary:

The purpose of this study is to examine whether an investigational drug called niraparib can help delay worsening of advanced relapsed ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three previous courses of chemotherapy regimens (courses of treatment involving single agent or a combination of anti-cancer drugs used to treat cancer). Researchers aim to evaluate the safety and tolerability of niraparib, in addition to measuring how long the drug delays cancer and its effect on the electrical activity of the heart.

Fibroids

Condition: 

Fibroids

Key Inclusion Criteria:

  • 18-70 years old
  • Have not yet signed surgical consent forms
  • Intend to undergo laparoscopic hysterectomy or myomectomy for uterine fibroids where morcellation (dividing and removing tissue) is anticipated to be needed for tissue extraction, but where other pathology is not suspected 

Summary:

This study focuses on patients who have elected to undergo surgery for uterine fibroids by a minimally invasive approach. The purpose of the study is to determine the type of patients who would benefit from video counseling before surgery for uterine fibroids. Researchers aim to determine whether video education counseling helps patients have a better understanding of the surgery they are about to undergo.

Patients will be asked if they wish to watch a short video that provides additional information and animations about their condition and surgery; watching this video is optional. Participants also will be asked to complete surveys.