The DETECT Study - Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in Tampons: Tampon and Tissue Sampling to Evaluate Markers for Detection of Endometrial and Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,700
- 试验地点
- 1
- 主要终点
- Endometrial Cancer
研究概览
简要总结
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. 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. 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.
In contrast to endometrial cancer, ovarian cancer is typically detected at advanced stages with poor survival since symptoms manifest only late in the disease process and are very unspecific. Racial disparities in ovarian cancer incidence and mortality are also much less pronounced. Racial disparities can manifest particularly when screening, symptom appraisal and early detection, and effective treatment interventions have important roles in determining outcomes of cancers.
OBJECTIVES:
The purpose of this study is to see if it is possible and acceptable for individuals to have an endometrial or ovarian sample collected by using a tampon placed in the vagina. The investigators will look at DNA in these samples. DNA is the genetic information participants inherited from their parents. The investigators want to see whether the investigators can find changes in DNA and proteins related to endometrial or ovarian cancer from tampon samples. Tests on the samples from tampons will help to understand endometrial and ovarian cancer. The samples collected during this study will be used for research related to both endometrial and ovarian cancer and non-cancer conditions.
ELIGIBILITY:
Women at least ≥18 years undergoing clinically-indicated hysterectomy and/or bilateral salpingo-oophorectomy for endometrial or ovarian cancer, cancer precursors, or benign conditions.
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 +/- ovary 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 5 years after the study. Additional blood may be taken from patient if patient agrees.
- Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples.
详细描述
BACKGROUND:
Endometrial cancer is the most common and second deadliest gynecological cancer in women in the United States, with over 65,000 new cases and 12,000 deaths expected to occur in 2022. Unlike most cancers, endometrial cancer incidence and mortality are increasing, due primarily to rising rates of aggressive subtypes of endometrial cancer (non-endometroid tumors, i.e., serous or clear cell histology), which are more common in Black or African American (henceforth referred to as "Black") women. In addition to being more clinically aggressive, these non-endometrioid tumors are thought to have different risk factor profiles, precursor lesions, and molecular features than the more common and less aggressive endometrioid subtypes.
The same morphologic subtypes (serous and endometrioid) with similar molecular profiles are also found in ovarian cancers, which share many risk factors with endometrial cancers.
Racial disparities in endometrial cancer incidence and mortality have been reported, with 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals born with female sex organs (uterus, ovaries, including cis-gender female and transmasculine individuals, hereafter referred to as "women") scheduled for hysterectomy or bilateral salpingo-oopherectomy at the University of Alabama Birmingham's Division of Gynecologic Oncology or Department of Gynecology
- •Age >18 years. We have chosen this age range to include both peri- and postmenopausal women, who are at greatest risk for endometrial cancer.
- •Ability of study participant 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 Spanish, 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).
排除标准
- •Women who are pregnant are excluded from gynecologic surgery and are therefore not eligible to participate.
- •Individuals who were not born with female sex organs at birth (i.e., cis-gender males and transfeminine individuals) are not eligible for this study as they are not at risk for developing endometrial and ovarian cancer.
研究组 & 干预措施
Cases
Women undergoing clinically-indicated hysterectomy +/- bilateral salpingo-oophorectomy for endometrial or ovarian cancer or precursors
Controls
Women undergoing clinically-indicated hysterectomy for benign conditions
结局指标
主要结局
Endometrial Cancer
时间窗: Enrollment or at time of surgery
Women with histologically confirmed diagnosis of endometrial or ovarian cancer
Endometrial cancer precursors
时间窗: Enrollment or at time of surgery
Women with histologically confirmed diagnosis of precursors (e.g., atypical hyperplasia)
Non-malignant uterus
时间窗: Enrollment or at time of surgery
Women with fibroids, polyps, endometrial hyperplasia without atypia, adenomyosis, normal endometrium, or other benign conditions determined by histology and/or clinical imaging.
次要结局
- Acceptability of tampon sampling(Prior to surgery)
- Feasibility of tampon sampling(During and immediately after surgery)
研究者
Rebecca Arend
Associate Professor
University of Alabama at Birmingham