The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 31, 2020 |
| Contact: | Nicolas Wentzensen, M.D. |
| Email: | wentzenn@mail.nih.gov |
| Phone: | (301) 435-3975 |
The DETECT Study - Discovery and Evaluation of Testing for Endometrial Cancer in Tampons
Background:
Endometrial cancer is a common and deadly cancer for women. It is getting more common and
deadly because risk factors like age and obesity are increasing. It is highly curable if it
is identified early. But there may be no symptoms early or they may be missed. Also, this
cancer is becoming more common and deadly for black women than white women. Researchers want
to find better ways to take samples and test them for this cancer. They want to study this
for a racially diverse population. One way to take samples might be from a tampon.
Objective:
To see if it is possible and acceptable to collect an endometrial sample from women by using
a tampon placed in the vagina.
Eligibility:
Women at least 45 years old who are having a hysterectomy
Design:
Participants will put a tampon in their vagina at least 30 minutes before their surgery.
Participants will take a short survey.
The tampon will be collected during the surgery.
A small piece of tissue will be collected from the uterus that is removed in surgery.
Participants will give a blood sample.
Before or after surgery, participants will answer questions. These will be about their
medical history and basic data such as age and race.
Researchers will follow participants medical records for up to 3 years after the study.
Researchers will study the samples and tampons. They will compare how well cancer and other
markers are detected between the samples.
Endometrial cancer is a common and deadly cancer for women. It is getting more common and
deadly because risk factors like age and obesity are increasing. It is highly curable if it
is identified early. But there may be no symptoms early or they may be missed. Also, this
cancer is becoming more common and deadly for black women than white women. Researchers want
to find better ways to take samples and test them for this cancer. They want to study this
for a racially diverse population. One way to take samples might be from a tampon.
Objective:
To see if it is possible and acceptable to collect an endometrial sample from women by using
a tampon placed in the vagina.
Eligibility:
Women at least 45 years old who are having a hysterectomy
Design:
Participants will put a tampon in their vagina at least 30 minutes before their surgery.
Participants will take a short survey.
The tampon will be collected during the surgery.
A small piece of tissue will be collected from the uterus that is removed in surgery.
Participants will give a blood sample.
Before or after surgery, participants will answer questions. These will be about their
medical history and basic data such as age and race.
Researchers will follow participants medical records for up to 3 years after the study.
Researchers will study the samples and tampons. They will compare how well cancer and other
markers are detected between the samples.
BACKGROUND:
- Endometrial cancer is the most common and second deadliest gynecological cancer in women
in the United States, with over 63,000 new cases and 11,000 deaths expected to occur in
2018. Unlike most cancers, endometrial cancer incidence and mortality are increasing,
due to increases in risk factors such as obesity and population aging.
- Racial disparities in endometrial cancer incidence and mortality have been reported,
with black or African American (henceforth referred to as black ) women experiencing
more rapid increases in incidence, as well as a higher burden of endometrial cancer
mortality compared to other racial/ethnic groups. The underlying basis for these
disparities is likely multifactorial, involving biological differences, as well as
clinical factors related to access to care, delayed diagnosis, and differences in
treatment and surgical management.
- If identified early, endometrial cancer can be highly curable; however, the earliest
stages may be asymptomatic, and clinical symptoms are often missed. Combining sensitive
molecular testing approaches with non-invasive sampling techniques may to lead to the
development of novel endometrial cancer early detection approaches with the potential to
overcome disparities in access to care and time to diagnosis and treatment. We and
others have recently shown that vaginal tampons offer an acceptable and feasible method
for identifying molecular markers with high sensitivity and specificity for endometrial
cancer. Importantly, these proof-of-principle studies have been conducted in
predominantly non-Hispanic white (white) populations, and studies of molecular markers
for endometrial cancer, including those involving vaginal tampons, are lacking in black
women.
OBJECTIVES:
-The goal of this study is to evaluate the acceptability, feasibility, and clinical
performance of vaginal tampon sampling for molecular testing of endometrial cancer early
detection biomarkers in a racially diverse clinical population.
ELIGIBILITY:
-Eligible participants will include women aged greater than or equal to 45 years undergoing
clinically-indicated hysterectomy for endometrial cancer, endometrial cancer precursors, or
benign conditions at the University of Alabama s Division of Gynecologic Oncology.
DESIGN:
-This is a case-control study with prospective follow-up of the electronic health record or
up to 3 years. Cases will be defined as women with histologically-confirmed endometrial
cancer or cancer precursors diagnosed at hysterectomy. Controls will have no histologic
evidence of endometrial cancer or endometrial cancer precursors diagnosed at
hysterectomy.
-The primary endpoints of this study will be: 1) The acceptability and feasibility of vaginal
tampon sampling in a racially diverse clinical population, assessed by evaluating
approximately 10 items from a brief survey regarding tampon sampling and the DNA yield from
the vaginal tampon, respectively and 2) The prevalence, sensitivity, and specificity of
endometrial cancer driver mutations in tampon and tissue samples in cases and controls.
- Endometrial cancer is the most common and second deadliest gynecological cancer in women
in the United States, with over 63,000 new cases and 11,000 deaths expected to occur in
2018. Unlike most cancers, endometrial cancer incidence and mortality are increasing,
due to increases in risk factors such as obesity and population aging.
- Racial disparities in endometrial cancer incidence and mortality have been reported,
with black or African American (henceforth referred to as black ) women experiencing
more rapid increases in incidence, as well as a higher burden of endometrial cancer
mortality compared to other racial/ethnic groups. The underlying basis for these
disparities is likely multifactorial, involving biological differences, as well as
clinical factors related to access to care, delayed diagnosis, and differences in
treatment and surgical management.
- If identified early, endometrial cancer can be highly curable; however, the earliest
stages may be asymptomatic, and clinical symptoms are often missed. Combining sensitive
molecular testing approaches with non-invasive sampling techniques may to lead to the
development of novel endometrial cancer early detection approaches with the potential to
overcome disparities in access to care and time to diagnosis and treatment. We and
others have recently shown that vaginal tampons offer an acceptable and feasible method
for identifying molecular markers with high sensitivity and specificity for endometrial
cancer. Importantly, these proof-of-principle studies have been conducted in
predominantly non-Hispanic white (white) populations, and studies of molecular markers
for endometrial cancer, including those involving vaginal tampons, are lacking in black
women.
OBJECTIVES:
-The goal of this study is to evaluate the acceptability, feasibility, and clinical
performance of vaginal tampon sampling for molecular testing of endometrial cancer early
detection biomarkers in a racially diverse clinical population.
ELIGIBILITY:
-Eligible participants will include women aged greater than or equal to 45 years undergoing
clinically-indicated hysterectomy for endometrial cancer, endometrial cancer precursors, or
benign conditions at the University of Alabama s Division of Gynecologic Oncology.
DESIGN:
-This is a case-control study with prospective follow-up of the electronic health record or
up to 3 years. Cases will be defined as women with histologically-confirmed endometrial
cancer or cancer precursors diagnosed at hysterectomy. Controls will have no histologic
evidence of endometrial cancer or endometrial cancer precursors diagnosed at
hysterectomy.
-The primary endpoints of this study will be: 1) The acceptability and feasibility of vaginal
tampon sampling in a racially diverse clinical population, assessed by evaluating
approximately 10 items from a brief survey regarding tampon sampling and the DNA yield from
the vaginal tampon, respectively and 2) The prevalence, sensitivity, and specificity of
endometrial cancer driver mutations in tampon and tissue samples in cases and controls.
- INCLUSION CRITERIA:
- Women scheduled for hysterectomy for endometrial cancer, endometrial cancer
precursors, or benign conditions at the University of Alabama Birmingham s Division of
Gynecologic Oncology.
- Age greater than or equal to 45 years. We have chosen this age range to include both
peri- and postmenopausal women, who are at greatest risk for endometrial cancer. Women
younger than 45 years of age will not be included because they are at very low risk
for endometrial cancer and therefore are likely not the target population for early
detection of endometrial cancer.
- Ability of subject to understand and the willingness to sign a written informed
consent document. Women who do not meet this criterion include potential participants
who do not speak English, or have physical, mental, or emotional problems that prevent
them from comprehending the nature of the study. If the potential participant has
trouble reading the document, the designated study staff person may read the document
to the patient, to include the basic elements of the informed consent document, per 45
CFR 46.116 (a).
EXCLUSION CRITERIA:
- Women who are pregnant are excluded from gynecologic surgery and are therefore not
eligible to participate.
- Men are not eligible for this study as this is a disease of a female organ.
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