Molecular Analysis of Factors Involved in Benign Reproductive Tract Diseases

SH

Shannon Hawkins

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years Gender: Female Phase: N/A 5 Locations

Brief Description

What is the purpose of this study?
The purpose of this study is to collect female reproductive tract tissues to investigate the key molecular events regulating endometriosis. Our central hypothesis is that by using well-characterized tissues, we can create novel models to improve treatments for endometriosis.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Women with suspected endometriosis (pelvic pain, adnexal mass, infertility), endometrial cancer, or ovarian cancer who are undergoing surgery for one of these diseases will be identified by her primary surgeon. For non-endometriosis control patients, these women will be selected based on a diagnosis of menorrhagia or symptomatic uterine fibroids or pelvic organ prolapse. All patients will be approached for recruitment only after agreeing to surgery. No surgery will be performed for the sole purpose of this study.

Detailed Description

What will happen during the study?

The purpose of this study is to create new immortalized endometriotic cell lines. This is a laboratory-based research protocol in which prospectively collected specimens of tissue and whole blood will be obtained from women undergoing gynecologic surgery. Because endometriosis is composed of both epithelial and stromal cells (1), we will use fresh tissues obtained at time of surgery (endometriotic lesions, endometriomas) to create primary cultures of both endometriotic epithelial and stromal cells. 

As controls, we will use fresh endometrial tissues at time of hysterectomy from women without endometriosis to create primary cultures of endometrial epithelial and endometrial stromal cells. 

These primary cultures will be immortalized using lentiviral system that expresses human telomerase reverse transcriptase (hTERT) (10, 11). These new immortalized cell lines will be characterized, used in future studies, and eventually used in our novel 3D bioprinted model system.

Eligibility of study

Inclusion Criteria
•    Female patients over 18 years of age, undergoing surgery for suspected endometriosis: pelvic pain, adnexal mass(es), infertility, endometrioma.
•    Female patients over 18 years of age, undergoing hysterectomy for non-endometriosis: menorrhagia, symptomatic uterine fibroids, pelvic organ prolapse, adnexal masses (not thought to be endometriomas).
•    Pregnant females, including patients undergoing surgery for presumed ectopic pregnancy 
•    Under 18 years of age
•    Pregnant females, including patients undergoing surgery for presumed ectopic pregnancy 
•    Under 18 years of age

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.