Ignite Creation Date:
2024-05-06 @ 1:47 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01907789
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2013-07-18
Brief Title:
Prophylactic Salpingectomy With Delayed Oophorectomy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prophylactic Salpingectomy With Delayed Oophorectomy Risk-Reducing Salpingo-Oophorectomy and Ovarian Cancer Screening Among BRCA Mutation Carriers A Proof-of-Concept Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical research study is to compare ovarian cancer screening risk-reducing salpingo-oophorectomy RRSO and prophylactic salpingectomy with delayed oophorectomy PSDO The safety of RRSO and PSDO will also be studied
Ovarian cancer screening does not involve a surgical procedure Instead physical exams blood tests and ultrasound are used to check for ovarian fallopian tube and peritoneal cancer
The surgical procedures RRSO and PSDO are designed to lower your risk of ovarian cancer
In RRSO the fallopian tubes and ovaries are removed at the same time
In PSDO the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause The ovaries are removed at a later date The main goal of this study is to learn how many patients actually have their ovaries removed at a later date Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer
Ovarian cancer screening does not involve a surgical procedure Instead physical exams blood tests and ultrasound are used to check for ovarian fallopian tube and peritoneal cancer
The surgical procedures RRSO and PSDO are designed to lower your risk of ovarian cancer
In RRSO the fallopian tubes and ovaries are removed at the same time
In PSDO the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause The ovaries are removed at a later date The main goal of this study is to learn how many patients actually have their ovaries removed at a later date Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer
Detailed Description:
This study has 3 options ovarian cancer screening PSDO and RRSO You may choose which study group you want to take part in However you must let the researchers know what your choice is before any testing for the study begins The 3 study groups are described in detail below
GROUP 1 OVARIAN CANCER SCREENING
Study Visits
For this group there is no testing required before starting the study If you agree to be in Group 1 the following tests and procedures will be performed
You will have a physical exam including a pelvic exam
You will have a transvaginal ultrasound ultrasound inside the vagina to look at your ovaries and fallopian tubes
Blood about 2 tablespoons will be drawn to measure your CA125 levels This test is used to screen for ovarian cancer
You will complete a questionnaire about your quality of life This should take up to 15 minutes
Every 6 months for up to 3 years
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for CA-125 testing
You will have a transvaginal ultrasound to look at your ovaries and fallopian tubes
At the end of Years 1 2 and 3 you will complete the quality-of-life questionnaire
All of your test results will be discussed with you If any of your test results are abnormal the study doctor may ask you to have additional testing which may include CA-125 testing ultrasound andor a computed tomography CT scan or magnetic resonance imaging MRI If the results show cancer the study doctor will refer you to a gynecologic oncologist a doctor for womens cancer andor recommend that you have your ovaries and fallopian tubes removed
Length of Study
You may have study visits for up to 3 years You will be taken off study early if you develop cancer or if you are unable to follow study directions
At any time or preferably at the end of 3 years you will have the option to cross over and choose one of the treatment options Group 2 or 3
Follow-Up
One 1 time a year after your last study visit for as long as needed the study staff will contact you by phone e-mail or letter to ask if you have had any changes in your medical history If you are called the calls should last about 5 minutes
GROUP 2 FALLOPIAN TUBE REMOVAL WITH DELAYED OVARY REMOVAL PSDO
Salpingectomy
If you are found to be eligible to take part in this study in Group 2 the study doctor will discuss the salpingectomy surgery with you in detail including the risks and possible benefits You will be asked to sign a surgical consent form After that the salpingectomy will be scheduled
Most patients have salpingectomy performed as an outpatient procedure This means that you will likely go home the day of your surgery If the study doctor plans to have you stay overnight in the hospital for any reason it will be discussed with you
During the surgery the inside of your abdomen will be looked at and both of your fallopian tubes will be removed If the study doctor finds anything during the surgery that may be cancerous a tissue sample or a complete ovary will be removed during surgery and tested If cancer is found a gynecologic oncologist would perform your cancer surgery
Post-Salpingectomy Follow-Up
The study staff will call you 1 day and 1 week after surgery to ask how you are doing The calls should last about 5 minutes
One 1 month after surgery
You will have a physical exam including an exam of your surgical incisions wounds
You will complete the quality-of-life questionnaire
The pathology tissue results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
Ovarian Cancer Screening Period
Every 6 months or until your delayed oophorectomy after the salpingectomy
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for CA-125 testing
You will have a transvaginal ultrasound to look at your ovaries
You will complete the quality-of-life questionnaire 1 time a year until 1 year after your delayed oophorectomy
Pre-Oophorectomy Testing
After the 3-year screening period you will have a pre-oophorectomy visit The following tests and procedures will be performed
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for routine tests and CA-125 testing
You will have a transvaginal ultrasound to look at your ovaries if this has not been done in the last 6 months
You will complete the quality-of-life questionnaire if this has not been done in the last 6 months
You may have other tests performed if the study doctor thinks it is needed
Oophorectomy
If your pre-surgical testing is normal the study doctor will discuss the planned surgery with you in detail including the risks and possible benefits You will be asked to sign a surgical consent form After that the oophorectomy will be scheduled
Most patients have oophorectomy performed as an outpatient procedure This means that you will likely go home the day of your surgery If the study doctor plans to have you stay overnight in the hospital for any reason it will be discussed with you
During the surgery the inside of your abdomen will be looked at and both of your ovaries will be removed If the study doctor finds anything during the surgery that may be cancerous a tissue sample will be removed during surgery and tested
Post-Oophorectomy Follow-Up
The study staff will call you 1 day and 1 week after surgery to ask how you are doing
One 1 month after surgery
You will have a physical exam including an exam of your surgical incisions
You will complete the quality-of-life questionnaire
The pathology results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
At 6 months and 1 year after surgery you will complete the quality-of-life questionnaire
At 1 year after surgery
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for CA-125 testing
All of your test results will be discussed with you If any of your test results are abnormal the study doctor may ask you to have additional testing which may include CA-125 testing ultrasound andor a CT scan or MRI If the results show cancer the study doctor will refer you to a gynecologic oncologist
Length of Study
You will have study visits until 1 year after your oophorectomy You will be taken off study early if you develop cancer or if you are unable to follow study directions
Follow-Up
One 1 time a year after your last study visit for as long as needed the study staff will contact you by phone e-mail or letter to ask if you have had any changes in your medical history
GROUP 3 REMOVAL OF FALLOPIAN TUBES AND OVARIES AT THE SAME TIME RRSO
RRSO
If you are found to be eligible to take part in this study in Group 3 the study doctor will discuss the surgery with you in detail including the risks and possible benefits You will be asked to sign a surgical consent form After that the RRSO will be scheduled
Most patients have RRSO performed as an outpatient procedure This means that you will likely go home the day of your surgery If the study doctor plans to have you stay overnight in the hospital for any reason it will be discussed with you
During the surgery the inside of your abdomen will be looked at and both of your ovaries and fallopian tubes will be removed If the study doctor finds anything during the surgery that may be cancerous a tissue sample will be removed during surgery and tested
The pathology results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
Post-Surgery Follow-Up
The study staff will call you 1 day and 1 week after surgery to ask how you are doing
One 1 month after surgery
You will have a physical exam including an exam of your surgical incisions
You will complete the quality-of-life questionnaire
The pathology results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
At 6 months and 1 year after surgery you will complete the quality-of-life questionnaire
At 1 year after surgery
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn to measure your CA-125
All of your test results will be discussed with you If any of your test results are abnormal the study doctor may ask you to have additional testing which may include CA-125 testing ultrasound andor a CT scan or MRI If the results show cancer the study doctor will refer you to a gynecologic oncologist
Length of Study
You will have study visits for up to 1 year after surgery You will be taken off study early if you develop cancer or if you are unable to follow study directions
Follow-Up
One 1 time a year after your last study visit for as long as needed the study staff will contact you by phone e-mail or letter to ask if you have had any changes in your medical history
This is an investigational study At this time the only known method that may lower your risk of ovarian cancer is to have both of your ovaries and fallopian tubes removed RRSO Screening for ovarian cancer does not lower the risk that you will develop cancer PSDO has not previously been studied and may not lower your ovarian cancer risk PSDO is currently being used for research purposes only
Up to 80 women will take part in this multicenter study Up to 60 will be enrolled at MD Anderson
GROUP 1 OVARIAN CANCER SCREENING
Study Visits
For this group there is no testing required before starting the study If you agree to be in Group 1 the following tests and procedures will be performed
You will have a physical exam including a pelvic exam
You will have a transvaginal ultrasound ultrasound inside the vagina to look at your ovaries and fallopian tubes
Blood about 2 tablespoons will be drawn to measure your CA125 levels This test is used to screen for ovarian cancer
You will complete a questionnaire about your quality of life This should take up to 15 minutes
Every 6 months for up to 3 years
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for CA-125 testing
You will have a transvaginal ultrasound to look at your ovaries and fallopian tubes
At the end of Years 1 2 and 3 you will complete the quality-of-life questionnaire
All of your test results will be discussed with you If any of your test results are abnormal the study doctor may ask you to have additional testing which may include CA-125 testing ultrasound andor a computed tomography CT scan or magnetic resonance imaging MRI If the results show cancer the study doctor will refer you to a gynecologic oncologist a doctor for womens cancer andor recommend that you have your ovaries and fallopian tubes removed
Length of Study
You may have study visits for up to 3 years You will be taken off study early if you develop cancer or if you are unable to follow study directions
At any time or preferably at the end of 3 years you will have the option to cross over and choose one of the treatment options Group 2 or 3
Follow-Up
One 1 time a year after your last study visit for as long as needed the study staff will contact you by phone e-mail or letter to ask if you have had any changes in your medical history If you are called the calls should last about 5 minutes
GROUP 2 FALLOPIAN TUBE REMOVAL WITH DELAYED OVARY REMOVAL PSDO
Salpingectomy
If you are found to be eligible to take part in this study in Group 2 the study doctor will discuss the salpingectomy surgery with you in detail including the risks and possible benefits You will be asked to sign a surgical consent form After that the salpingectomy will be scheduled
Most patients have salpingectomy performed as an outpatient procedure This means that you will likely go home the day of your surgery If the study doctor plans to have you stay overnight in the hospital for any reason it will be discussed with you
During the surgery the inside of your abdomen will be looked at and both of your fallopian tubes will be removed If the study doctor finds anything during the surgery that may be cancerous a tissue sample or a complete ovary will be removed during surgery and tested If cancer is found a gynecologic oncologist would perform your cancer surgery
Post-Salpingectomy Follow-Up
The study staff will call you 1 day and 1 week after surgery to ask how you are doing The calls should last about 5 minutes
One 1 month after surgery
You will have a physical exam including an exam of your surgical incisions wounds
You will complete the quality-of-life questionnaire
The pathology tissue results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
Ovarian Cancer Screening Period
Every 6 months or until your delayed oophorectomy after the salpingectomy
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for CA-125 testing
You will have a transvaginal ultrasound to look at your ovaries
You will complete the quality-of-life questionnaire 1 time a year until 1 year after your delayed oophorectomy
Pre-Oophorectomy Testing
After the 3-year screening period you will have a pre-oophorectomy visit The following tests and procedures will be performed
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for routine tests and CA-125 testing
You will have a transvaginal ultrasound to look at your ovaries if this has not been done in the last 6 months
You will complete the quality-of-life questionnaire if this has not been done in the last 6 months
You may have other tests performed if the study doctor thinks it is needed
Oophorectomy
If your pre-surgical testing is normal the study doctor will discuss the planned surgery with you in detail including the risks and possible benefits You will be asked to sign a surgical consent form After that the oophorectomy will be scheduled
Most patients have oophorectomy performed as an outpatient procedure This means that you will likely go home the day of your surgery If the study doctor plans to have you stay overnight in the hospital for any reason it will be discussed with you
During the surgery the inside of your abdomen will be looked at and both of your ovaries will be removed If the study doctor finds anything during the surgery that may be cancerous a tissue sample will be removed during surgery and tested
Post-Oophorectomy Follow-Up
The study staff will call you 1 day and 1 week after surgery to ask how you are doing
One 1 month after surgery
You will have a physical exam including an exam of your surgical incisions
You will complete the quality-of-life questionnaire
The pathology results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
At 6 months and 1 year after surgery you will complete the quality-of-life questionnaire
At 1 year after surgery
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn for CA-125 testing
All of your test results will be discussed with you If any of your test results are abnormal the study doctor may ask you to have additional testing which may include CA-125 testing ultrasound andor a CT scan or MRI If the results show cancer the study doctor will refer you to a gynecologic oncologist
Length of Study
You will have study visits until 1 year after your oophorectomy You will be taken off study early if you develop cancer or if you are unable to follow study directions
Follow-Up
One 1 time a year after your last study visit for as long as needed the study staff will contact you by phone e-mail or letter to ask if you have had any changes in your medical history
GROUP 3 REMOVAL OF FALLOPIAN TUBES AND OVARIES AT THE SAME TIME RRSO
RRSO
If you are found to be eligible to take part in this study in Group 3 the study doctor will discuss the surgery with you in detail including the risks and possible benefits You will be asked to sign a surgical consent form After that the RRSO will be scheduled
Most patients have RRSO performed as an outpatient procedure This means that you will likely go home the day of your surgery If the study doctor plans to have you stay overnight in the hospital for any reason it will be discussed with you
During the surgery the inside of your abdomen will be looked at and both of your ovaries and fallopian tubes will be removed If the study doctor finds anything during the surgery that may be cancerous a tissue sample will be removed during surgery and tested
The pathology results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
Post-Surgery Follow-Up
The study staff will call you 1 day and 1 week after surgery to ask how you are doing
One 1 month after surgery
You will have a physical exam including an exam of your surgical incisions
You will complete the quality-of-life questionnaire
The pathology results from your surgery will be discussed with you at either the 1-week phone call or the 1-month visit If the results show cancer the study doctor will refer you to a gynecologic oncologist
At 6 months and 1 year after surgery you will complete the quality-of-life questionnaire
At 1 year after surgery
You will have a physical exam including a pelvic exam
Blood about 2 tablespoons will be drawn to measure your CA-125
All of your test results will be discussed with you If any of your test results are abnormal the study doctor may ask you to have additional testing which may include CA-125 testing ultrasound andor a CT scan or MRI If the results show cancer the study doctor will refer you to a gynecologic oncologist
Length of Study
You will have study visits for up to 1 year after surgery You will be taken off study early if you develop cancer or if you are unable to follow study directions
Follow-Up
One 1 time a year after your last study visit for as long as needed the study staff will contact you by phone e-mail or letter to ask if you have had any changes in your medical history
This is an investigational study At this time the only known method that may lower your risk of ovarian cancer is to have both of your ovaries and fallopian tubes removed RRSO Screening for ovarian cancer does not lower the risk that you will develop cancer PSDO has not previously been studied and may not lower your ovarian cancer risk PSDO is currently being used for research purposes only
Up to 80 women will take part in this multicenter study Up to 60 will be enrolled at MD Anderson
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 |
|---|---|---|---|
| NCI-2015-00465 | REGISTRY | NCI CTRP | None |