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临床试验/NCT06436248
NCT06436248进行中(未招募)不适用

Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer

Abramson Cancer Center at Penn Medicine1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
To assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through interviews

研究概览

简要总结

The overall goal of the Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer (PROMISE) study is to better understand how women may incorporate both polygenic risk score (PRS) and novel early detection strategies in their decisions regarding cancer screening and risk reducing surgery. This study will conduct qualitative interviews to better understand women's attitudes regarding polygenic risk score (PRS) and early detection assays.

详细描述

First, the investigators will conduct qualitative interviews to better understand women's attitudes regarding polygenic risk score (PRS) and early detection assays. Participants will include English-speaking adult women with BRCA1 or BRCA2 pathogenic variants (PV) who have not previously undergone risk-reducing salpingo-oophorectomy (RRSO) (n=24). Interviews will be led by a trained member of the study team using a semi-structured interview guide in order to review definitions of test characteristics (e.g., sensitivity, specificity) and discuss participants' understanding and perceived importance of such test characteristics, and the potential impact of polygenic risk score (PRS) and early detection assay results in informing their cancer prevention decisions. Interviews will be audio-recorded utilizing Zoom audio recording and transcribed using 3Play Media transcription service (Health Insurance Portability and Accountability Act/HIPAA compliant). The investigators will lead analysis of the de-identified transcripts through a process of independent and collaborative thematic content analysis, an established method in qualitative research in order to establish key themes related to clarifying participants' willingness and concerns (e.g., discomfort with test characteristics, perceived ambiguity) for adopting these emerging tests.

Findings from these qualitative interviews will also inform development of hypothetical scenarios that will then be evaluated in a subsequent questionnaire administered to 175-200 English-speaking adult women with BRCA1 or BRCA2 Pathogenic Variants who have not previously undergone risk-reducing oophorectomy or risk-reducing mastectomy. The objective of this survey will be to further evaluate women's decision-making responses to hypothetical polygenic risk score (PRS) and early detection assays, and to determine if there are test characteristics and result thresholds that appear meaningful. Details of this questionnaire and its administration will be included in a future amendment to this current protocol.

Results from year 1 will be used to develop patient materials to use in providing individualized polygenic risk score (PRS) and early detection assay results back to patients in years 2-3. Taken together, investigators hope that this project will provide an estimate on the absolute magnitude of risk which would result in risk reducing surgery within a year, and how a negative early detection assay might modulate such action.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, age 25 or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
  • Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified.
  • English-fluent; the surveys and interviews were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.

排除标准

  • Previous receipt of any prophylactic oophorectomy
  • Personal history of ovarian cancer
  • Major psychiatric illness or cognitive impairment that in the judgment of the study investigators would preclude study participation.
  • Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.

结局指标

主要结局

To assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through interviews

时间窗: 1 year

The investigators will assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through semi-structured interviews and thematic content analyses.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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