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临床试验/NCT05909410
NCT05909410尚未招募不适用

Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Number of patients using currently CHCs

研究概览

简要总结

Combined hormonal contraceptives (CHCs), according to the opinion by The Manchester International Consensus Group, should be considered for women wishing contraception because also positively impact endometrial cancer and ovarian cancer risk. The awareness of the effects of hormonal therapies in women at high risk of developing endometrial cancer, colorectal, breast, or ovarian cancer, such as those affected by Lynch syndrome (LS), is currently limited, with few published studies addressing these populations. Making informed decisions about CHC use in this context necessitates careful consideration of individual cancer risk and the potential benefits and risks associated with CHC use. Accurate information regarding the oncological risks associated with CHC use is essential for facilitating shared decision-making between women and their healthcare providers in this patient population.

This prospective study aims to evaluate the knowledge, attitudes, and beliefs of women with LS concerning CHCs and their potential effects on specific disease development and cancer risk, comparing them to the general population. By considering psychosocial factors and individual perceptions of cancer risk, this study seeks to contribute to informed decision-making, personalized counseling, and improved strategies for gynecologic cancer risk management in women with LS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with certain genetic diagnosis of Lynch syndrome and patients of reproductive age undergoing routinely gynecological visit

排除标准

  • for both groups, a prior history of oncological diseases and a personal history of endometrial cancer, colorectal cancer, ovarian cancer, or breast cancer.
  • for patients with Lynch syndrome, individuals who had undergone previous risk-reducing prophylactic surgical approaches such as (risk-reducing) colectomy, hysterectomy, early salpingectomy, and delayed oophorectomy, and risk-reducing salpingo-oophorectomy

结局指标

主要结局

Number of patients using currently CHCs

时间窗: Through study completion, an average of 1 month

Evaluation of the number (%) of patients using currently CHCs

Perception about the impact of CHCs on favoring/contrasting specific cancer onset

时间窗: Through study completion, an average of 1 month

By using a Likert scale (from -5 to +5)

Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset

时间窗: Through study completion, an average of 1 month

By using a Likert scale (from -5 to +5)

Perception about the impact of CHCs on favoring/contrasting specific symptoms onset

时间窗: Through study completion, an average of 1 month

By using a Likert scale (from -5 to +5)

Number of patients having used CHCs

时间窗: Through study completion, an average of 1 month

Evaluation of the number (%) of patients having used CHCs in the past

次要结局

未报告次要终点

研究者

发起方
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Ferrero

principal investigator

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

研究点 (1)

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