Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481754
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2007-06-01
Brief Title:
Benign Reproductive Tissue Analysis for Endometrial Cancer Markers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Benign Reproductive Tissue Evaluation BRTE Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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-Womens 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
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-Womens 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-C-N109 | None | None | None |