Ovarian CancerNCT02109367
Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
An observational study of Ovarian Cancer, run by Southern Illinois University at 1 site in United States.
Trial 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'. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9640
About this study
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.
Read the detailed description
This is a single cohort, exploratory pilot study of 60 participants to assess if ovarian cancer markers, cancer antigen-125 (CA-125) and human epididymis protein 4 (HE4), are measurable from cul-de-sac washings collected via culdocentesis. Immediately prior to the scheduled surgery, while the patient is under general anesthesia, a long, thin needle will be inserted through the wall of the vagina (just below the uterus) to access the cul-de-sac. A saline wash will then be performed and this fluid will be collected for analysis of tumor markers. CA-125 and HE4 levels will be compared to serum levels for correlation with a diagnosis of ovarian cancer. A urine sample will also be collected from this same cohort to measure estrogen metabolites. Estrogen metabolism is associated with cancer progression in estrogen sensitive tissues. Estrogen metabolites, 2-hydroxyestrone (2-OHE1) the "good" byproduct and 16α-hydroxyestrone (16α-OHE1) known as the "bad" byproduct, have been implicated in the development of breast cancer. Study investigators are proposing to expand the utility of this predictive ratio to ovarian cancer by measuring the potential imbalance of these metabolites.
If results indicate an association between cancer diagnosis and levels of CA-125 and HE4 or the ratio of estrogen metabolites from the urine, this could allow for a new minimally invasive, low-risk diagnostic modality for all suspected ovarian cancer cases. This would be particularly invaluable for patients at higher risk for poor surgical outcomes. Data from this pilot study will confirm the potential effect size needed to identify an optimal cut-point useful for the prediction of EOC within this study population.
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, ovarian mass, CA-125, HE4, culdocentesis, biomarker(s)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic mass | Women who present to the Gynecologic Oncology clinic with a pelvic mass who are scheduled to undergo surgical excision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HE4 and CA-125 from cul-de-sac wash
ELISA
Measured: baseline
Secondary outcomes (1)
2-hydroxyestrone (2-OHE1) and 16α-hydroxyestrone (16α-OHE1) from urine
ELISA
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2023
- Study completionMar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laurent Brard, MD, PhD, Principal investigator, Southern Illinois University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109367
- Sponsor's protocol ID
- BRARD-SIUSOM-14-001
- Other IDs
- 1R03CA181907-01
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2014
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19945742Bast 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.
PubMed 12743135Moore 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.
PubMed 18061248Partheen 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.
PubMed 22247801Sandri 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.
PubMed 23200911
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
- ClinicalTrials.gov ID
- NCT02109367
- Acronym / sponsor ID
- BRARD-SIUSOM-14-001
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, ovarian mass, CA-125, HE4, culdocentesis, biomarker(s)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Mar 2026 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single cohort, exploratory pilot study of 60 participants to assess if ovarian cancer markers, cancer antigen-125 (CA-125) and human epididymis protein 4 (HE4), are measurable from cul-de-sac washings collected via culdocentesis. Immediately prior to the scheduled surgery, while the patient is under general anesthesia, a long, thin needle will be inserted through the wall of the vagina (just below the uterus) to access the cul-de-sac. A saline wash will then be performed and this fluid will be collected for analysis of tumor markers. CA-125 and HE4 levels will be compared to serum levels for correlation with a diagnosis of ovarian cancer. A urine sample will also be collected from this same cohort to measure estrogen metabolites. Estrogen metabolism is associated with cancer progression in estrogen sensitive tissues. Estrogen metabolites, 2-hydroxyestrone (2-OHE1) the "good" byproduct and 16α-hydroxyestrone (16α-OHE1) known as the "bad" byproduct, have been implicated in the development of breast cancer. Study investigators are proposing to expand the utility of this predictive ratio to ovarian cancer by measuring the potential imbalance of these metabolites.
If results indicate an association between cancer diagnosis and levels of CA-125 and HE4 or the ratio of estrogen metabolites from the urine, this could allow for a new minimally invasive, low-risk diagnostic modality for all suspected ovarian cancer cases. This would be particularly invaluable for patients at higher risk for poor surgical outcomes. Data from this pilot study will confirm the potential effect size needed to identify an optimal cut-point useful for the prediction of EOC within this study population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic mass | – | –Women who present to the Gynecologic Oncology clinic with a pelvic mass who are scheduled to undergo surgical excision. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HE4 and CA-125 from cul-de-sac wash
Time frame: baseline
ELISA
1 secondary outcome
2-hydroxyestrone (2-OHE1) and 16α-hydroxyestrone (16α-OHE1) from urine
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 19945742Andersen 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.
- Background: PubMed 12743135Bast 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.
- Background: PubMed 18061248Moore 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.
- Background: PubMed 22247801Partheen 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.
- Background: PubMed 23200911Sandri 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Brard, MD, PhD principal investigator
Southern Illinois University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Southern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HE4 and CA-125 from cul-de-sac wash (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109367, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.