Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass

NCT02109367 | Completed DMC

• 2 other identifiers: BRARD-SIUSOM-14-0011R03CA181907-01
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves women who are scheduled to have surgery for a pelvic or ovarian mass that is suspicious for epithelial ovarian cancer (EOC). The physician will perform an additional procedure on all consented subjects known as 'culdocentesis'. This will be done just prior to their scheduled surgery while the patient is under general anesthesia. Culdocentesis is a procedure typically used to check for abnormal fluid in the space just behind the vagina. This pocket of space is called the cul-de-sac. The purpose of this study is to determine if levels of tumor markers, CA-125 and HE4, are measurable from the cul-de-sac fluid. If these tumor markers are measurable from the cul-de-sac fluid and correlate with the patient's diagnosis, this procedure may be used in the future as an additional diagnostic tool for EOC. In addition, a single urine sample will be collected from each patient to measure the ratio of "good" to "bad" estrogen. Investigators hypothesize this ratio will also correlate with EOC diagnosis. Study results could lead to development of an alternative, minimally invasive and low risk diagnostic tool in patients with an ovarian mass suspicious for malignancy.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; ovarian mass; CA-125; HE4; culdocentesis; biomarker(s)

Outcome Measures

Primary Outcomes (1)

• HE4 and CA-125 from cul-de-sac wash

  ELISA

  baseline

Secondary Outcomes (1)

• 2-hydroxyestrone (2-OHE1) and 16α-hydroxyestrone (16α-OHE1) from urine

  baseline

Study Arms (1)

Pelvic mass

Women who present to the Gynecologic Oncology clinic with a pelvic mass who are scheduled to undergo surgical excision.

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with a suspicious adnexal mass that could possibly be ovarian cancer who are scheduled for oophorectomy, bilateral salpingo-oophorectomy (BSO), hysterectomy via laparotomy or laparoscopy, hysterectomy/BSO, staging and/or debulking.

You may qualify if:

• Patients age ≥ 30.
• Adnexal mass or suspected ovarian carcinoma.
• Patient has been scheduled for oophorectomy, bilateral salpingo- oophorectomy (BSO), hysterectomy, hysterectomy/BSO, staging or debulking.
• Willingness to sign an Informed Consent document.

You may not qualify if:

• Patients previously diagnosed with a malignancy within the pelvis or abdomen.
• Patients in which culdocentesis is technically unfeasible due to previous surgery (extensive pelvic floor repair/colpocleisis) or other anatomic abnormalities that make the cul-de-sac inaccessible.

Sponsors & Collaborators

• Southern Illinois University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9640, United States

Location

Related Publications (5)

• Andersen MR, Goff BA, Lowe KA, Scholler N, Bergan L, Drescher CW, Paley P, Urban N. Use of a Symptom Index, CA125, and HE4 to predict ovarian cancer. Gynecol Oncol. 2010 Mar;116(3):378-83. doi: 10.1016/j.ygyno.2009.10.087. Epub 2009 Nov 28.

  PMID: 19945742 BACKGROUND

• Bast RC Jr. Status of tumor markers in ovarian cancer screening. J Clin Oncol. 2003 May 15;21(10 Suppl):200s-205s. doi: 10.1200/JCO.2003.01.068.

  PMID: 12743135 BACKGROUND

• Moore RG, Brown AK, Miller MC, Skates S, Allard WJ, Verch T, Steinhoff M, Messerlian G, DiSilvestro P, Granai CO, Bast RC Jr. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008 Feb;108(2):402-8. doi: 10.1016/j.ygyno.2007.10.017. Epub 2007 Dec 3.

  PMID: 18061248 BACKGROUND

• Partheen K, Kristjansdottir B, Sundfeldt K. Evaluation of ovarian cancer biomarkers HE4 and CA-125 in women presenting with a suspicious cystic ovarian mass. J Gynecol Oncol. 2011 Dec;22(4):244-52. doi: 10.3802/jgo.2011.22.4.244. Epub 2011 Dec 5.

  PMID: 22247801 BACKGROUND

• Sandri MT, Bottari F, Franchi D, Boveri S, Candiani M, Ronzoni S, Peiretti M, Radice D, Passerini R, Sideri M. Comparison of HE4, CA125 and ROMA algorithm in women with a pelvic mass: correlation with pathological outcome. Gynecol Oncol. 2013 Feb;128(2):233-8. doi: 10.1016/j.ygyno.2012.11.026. Epub 2012 Nov 28.

  PMID: 23200911 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

fluid sample infused and collected from the cul-de-sac

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Laurent Brard, MD, PhD

  Southern Illinois University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2024-04

Locations

US (1)