Oophorectomy for Benign ReasonsNCT00481754
Benign Reproductive Tissue Analysis for Endometrial Cancer Markers
An observational study of Oophorectomy for Benign Reasons and Hysterectomy, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic cancer in the United States. Currently, there are no markers (components of blood and tissue that determine who might be at risk for developing cancer) for endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Oophorectomy for Benign Reasons, Hysterectomy
- How many people
- 359 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2006to 13 Nov 2020
- 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 18 to 54 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing hysterectomy and/or unilateral or bilateral oophorectomy for benign indications, women at high risk or ovarian cancer or women with diagnosed ovarian cancer at Magee Women s Hospital.
Who may be able to join
- Inclusion criteria include: 18 years of age and older with:
- a benign condition for which subject has decided to have a hysterectomy (removal of the uterus), performed through an abdominal incision (open procedure) or through a laparoscope (minimally invasive procedure). The hysterectomy can be performed with or without removal of the tubes, ovaries or cervix.
- a benign cyst on the ovary(s) which subject has decided to have removed, with or without removal of the entire ovary. The surgery will be done with either an abdominal incision (open) or through a laparoscope (minimally invasive procedure).
- positive test for the BRCA 1 or 2 gene, which puts subject at an increased risk for breast cancer, and subject has decided to undergo surgery (either with an abdominal incision or through a laparoscope) to remove the uterus, tubes and ovaries, or any combination
- diagnosis of ovarian cancer or possible ovarian cancer and subject has been advised to undergo a hysterectomy (removal of the uterus), removal of the tubes and ovaries or any combination, with an abdominal incision or through a laparoscope.
Who cannot join
- Evidence on gross examination of the surgically removed uterus that there is a carcinoma invading the myometrium; however, post-operative diagnosis of early endometrial carcinoma will not be a cause for post-hoc exclusion after specimen and data collection. We will exclude women with a previous gynecologic or gastrointestinal cancer. At the discretion of the surgeon, we will exclude women with cancer in whom the study procedures may interfere with clinical management (e.g. staging of the cancer). We will exclude women who had neo-adjuvant chemotherapy and women who underwent chemoprevention of ovarian or breast cancer. We will also exclude women currently wearing an intrauterine device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Women's hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Benign Reproductive Tissue Evaluation (BRTE) Study
Background:
- Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic cancer in the United States.
- Currently, there are no markers (components of blood and tissue that determine who might be at risk for developing cancer) for endometrial cancer.
Read more
Objectives:
-To see if women who are undergoing hysterectomy are willing to provide blood and tissue samples to help doctors identify markers that would indicate increased risk for developing endometrial cancer.
Eligibility:
-Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others at Magee-Women's Hospital in Pittsburgh, Penn.
Design:
- Patients' medical records are reviewed and patients complete a questionnaire including information on race and ethnic background, education, marital status, family history, height, weight, pregnancy history, smoking history, medication history, history about menstrual periods and menopausal symptoms.
- Patients provide blood and urine samples before surgery.
- A sample of fat tissue is removed during surgery in patients undergoing abdominal surgery.
- Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are collected and analyzed for markers for endometrial cancer.
Read the detailed description
Our hypothesis is that silent molecular lesions, defined as molecular alterations
detectable in histologically normal endometrial, ovarian, and tubal tissues, represent markers of cancer risk. Incessant ovulation represents one of the most widely-recognized models to explain the pathogenesis of ovarian cancer, with women who have had a high number of lifetime ovulatory menstrual cycles being at increased cancer risk because of repeated ovulation-related injury to, and repair of, ovarian surface epithelium (OSE). This extremely delicate single layer of cells exfoliates easily on handling, with the majority of cells typically being lost in routine handling, when collected post-operatively. Furthermore, the identification of early stage ovarian cancer is uncommon, and the vast majority of ovarian cancers are not associated with recognizable precursors. The lack of effective techniques for collecting and studying OSE in the laboratory represents a major barrier to molecular studies designed to uncover the etiology and early pathogenesis of ovarian cancer. This proposal will develop a collection method for OSE, and demonstrate its utility for various molecular analyses. Recent evidence suggests that a subset of ovarian cancers may originate in the fallopian tubes. Therefore, we will pilot the collection of cells from the fallopian tubes. If successful, the collection of OSE and fallopian tube cells will provide the basis for larger studies aimed at identifying early molecular events in ovarian carcinogenesis.
In this pilot, we will collect endometrial and ovarian tissues (that would otherwise have been discarded without histopathologic examination) from 125 hysterectomy and/or unilateral or bilateral oophorectomy specimens obtained from women ages 18 and older who were operated on for benign indications. As an amendment to this active protocol, we propose demonstrating the feasibility of obtaining intra-operative cytobrushings of ovarian surface epithelial cells on 50 women to be accrued onto the study, which will include women having hysterectomy (or unilateral oophorectomy) alone without removal of the ovaries at the time of surgery. Furthermore, we will extend the collection to cells from the fallopian tubes in 225 women for a total population of 400.
We will administer a questionnaire assessing endometrial and ovarian cancer risk factors and gynecologic history; obtain blood and urine; and obtain carefully-mapped frozen and fixed endometrial and ovarian tissues. We will immunostain endometrial tissues to assess the presence, number, location, and size of foci containing PTEN-null glands, which represents a validated surrogate of mutations in the PTEN tumor suppressor gene. This pilot will demonstrate the feasibility of executing this complex protocol; determine the number and spacing of sections required to accurately and efficiently assess the PTEN status of the endometrium; and provide data for developing power estimates needed to propose a full-scale study with a sufficient number of subjects to test our hypothesis that PTEN abnormalities account for a substantial proportion of the risk associated with recognized epidemiologic endometrial cancer risk factors. It will assess the feasibility of performing molecular analyses on ovarian surface epithelial cells and tubal cells collected intra-operatively, and correlating molecular findings with known ovarian cancer risk factors. If successful, this will provide the basis for larger studies aimed at identifying early molecular events in
ovarian carcinogenesis, particularly in the setting of women at increased genetic
risk of ovarian cancer. The pilot itself will also provide an extremely valuable
repository for future biomarker pilot studies.
- Conditions
- Oophorectomy for Benign Reasons, Hysterectomy
- Keywords
- Endometrium, PTEN, Hormones, Carcinogenesis, Etiology, Tissue Evaluation, Questionnaire
- Medical subject headings
- Carcinogenesis
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 |
|---|---|---|
| Females with ovarian cancer | Recruited from Magee Women's Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of sampling and recruiting
Successful enrollment of women undergoing benign surgery, surgery because of high risk of ovarian cancer, or surgery because of diagnosed ovarian cancer.
Measured: Ongoing
Assessing PTEN abnormalities in benign tissue
Histological assessment of PTEN staining in normal endometrial tissues.
Measured: Ongoing
Optimization of PTEN testing
Improvement of PTEN staining after modifying the immunohistochemical staining protocol.
Measured: Ongoing
Feasibility of additional assays
Pilot testing of other assays on tissue and cytology samples.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study start24 Apr 2006
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oophorectomy for Benign ReasonsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nicolas Wentzensen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481754
- Sponsor's protocol ID
- 999906109
- Other IDs
- 06-C-N109
- Status last verified
- Nov 2020
- First submitted
- 1 Jun 2007
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Reproductive Tissue Evaluation (BRTE) Study
- ClinicalTrials.gov ID
- NCT00481754
- Acronym / sponsor ID
- 999906109
- Conditions
- Oophorectomy for Benign Reasons, Hysterectomy
- Keywords
- Endometrium, PTEN, Hormones, Carcinogenesis, Etiology, Tissue Evaluation, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Apr 2006 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 4 Jun 2007 (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.
Background:
- Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic cancer in the United States.
- Currently, there are no markers (components of blood and tissue that determine who might be at risk for developing cancer) for endometrial cancer.
Objectives:
-To see if women who are undergoing hysterectomy are willing to provide blood and tissue samples to help doctors identify markers that would indicate increased risk for developing endometrial cancer.
Eligibility:
-Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others at Magee-Women's Hospital in Pittsburgh, Penn.
Design:
- Patients' medical records are reviewed and patients complete a questionnaire including information on race and ethnic background, education, marital status, family history, height, weight, pregnancy history, smoking history, medication history, history about menstrual periods and menopausal symptoms.
- Patients provide blood and urine samples before surgery.
- A sample of fat tissue is removed during surgery in patients undergoing abdominal surgery.
- Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are collected and analyzed for markers for endometrial cancer.
Detailed description
Our hypothesis is that silent molecular lesions, defined as molecular alterations
detectable in histologically normal endometrial, ovarian, and tubal tissues, represent markers of cancer risk. Incessant ovulation represents one of the most widely-recognized models to explain the pathogenesis of ovarian cancer, with women who have had a high number of lifetime ovulatory menstrual cycles being at increased cancer risk because of repeated ovulation-related injury to, and repair of, ovarian surface epithelium (OSE). This extremely delicate single layer of cells exfoliates easily on handling, with the majority of cells typically being lost in routine handling, when collected post-operatively. Furthermore, the identification of early stage ovarian cancer is uncommon, and the vast majority of ovarian cancers are not associated with recognizable precursors. The lack of effective techniques for collecting and studying OSE in the laboratory represents a major barrier to molecular studies designed to uncover the etiology and early pathogenesis of ovarian cancer. This proposal will develop a collection method for OSE, and demonstrate its utility for various molecular analyses. Recent evidence suggests that a subset of ovarian cancers may originate in the fallopian tubes. Therefore, we will pilot the collection of cells from the fallopian tubes. If successful, the collection of OSE and fallopian tube cells will provide the basis for larger studies aimed at identifying early molecular events in ovarian carcinogenesis.
In this pilot, we will collect endometrial and ovarian tissues (that would otherwise have been discarded without histopathologic examination) from 125 hysterectomy and/or unilateral or bilateral oophorectomy specimens obtained from women ages 18 and older who were operated on for benign indications. As an amendment to this active protocol, we propose demonstrating the feasibility of obtaining intra-operative cytobrushings of ovarian surface epithelial cells on 50 women to be accrued onto the study, which will include women having hysterectomy (or unilateral oophorectomy) alone without removal of the ovaries at the time of surgery. Furthermore, we will extend the collection to cells from the fallopian tubes in 225 women for a total population of 400.
We will administer a questionnaire assessing endometrial and ovarian cancer risk factors and gynecologic history; obtain blood and urine; and obtain carefully-mapped frozen and fixed endometrial and ovarian tissues. We will immunostain endometrial tissues to assess the presence, number, location, and size of foci containing PTEN-null glands, which represents a validated surrogate of mutations in the PTEN tumor suppressor gene. This pilot will demonstrate the feasibility of executing this complex protocol; determine the number and spacing of sections required to accurately and efficiently assess the PTEN status of the endometrium; and provide data for developing power estimates needed to propose a full-scale study with a sufficient number of subjects to test our hypothesis that PTEN abnormalities account for a substantial proportion of the risk associated with recognized epidemiologic endometrial cancer risk factors. It will assess the feasibility of performing molecular analyses on ovarian surface epithelial cells and tubal cells collected intra-operatively, and correlating molecular findings with known ovarian cancer risk factors. If successful, this will provide the basis for larger studies aimed at identifying early molecular events in
ovarian carcinogenesis, particularly in the setting of women at increased genetic
risk of ovarian cancer. The pilot itself will also provide an extremely valuable
repository for future biomarker pilot studies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females with ovarian cancer | – | –Recruited from Magee Women's Hospital |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing hysterectomy and/or unilateral or bilateral oophorectomy for benign indications, women at high risk or ovarian cancer or women with diagnosed ovarian cancer at Magee Women s Hospital.
Key inclusion criteria (5 listed)
- Inclusion criteria include: 18 years of age and older with:
Key exclusion criteria (1 listed)
- Evidence on gross examination of the surgically removed uterus that there is a carcinoma invading the myometrium; however, post-operative diagnosis of early endometrial carcinoma will not be a cause for post-hoc exclusion after specimen and data collection. We will exclude women with a previous gynecologic or gastrointestinal cancer. At the discretion of the surgeon, we will exclude women with cancer in whom the study procedures may interfere with clinical management (e.g. staging of the cancer). We will exclude women who had neo-adjuvant chemotherapy and women who underwent chemoprevention of ovarian or breast cancer. We will also exclude women currently wearing an intrauterine device.
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
Feasibility of sampling and recruiting
Time frame: Ongoing
Successful enrollment of women undergoing benign surgery, surgery because of high risk of ovarian cancer, or surgery because of diagnosed ovarian cancer.
Assessing PTEN abnormalities in benign tissue
Time frame: Ongoing
Histological assessment of PTEN staining in normal endometrial tissues.
Optimization of PTEN testing
Time frame: Ongoing
Improvement of PTEN staining after modifying the immunohistochemical staining protocol.
Feasibility of additional assays
Time frame: Ongoing
Pilot testing of other assays on tissue and cytology samples.
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 17 Nov 2020.
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.
Nicolas Wentzensen, M.D. principal investigator
National Cancer Institute (NCI)
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 Oophorectomy for Benign Reasons and Hysterectomy, run by National Cancer Institute (NCI) 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 5 inclusion and 1 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 17 Nov 2020. 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?
Feasibility of sampling and recruiting (time frame: Ongoing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2020.