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

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Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Status

Not yet enrolling

Conditions

Contraception
Lynch Syndrome

Treatments

Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms

Study type

Observational

Funder types

Other

Identifiers

NCT05909410
HORMONES-LYNCH

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Female

Ages

18 to 52 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

180 participants in 2 patient groups

Patients with Lynch syndrome
Description:
Certain genetic diagnosis o fLynch syndrome
Treatment:
Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
Healthy patients of reproductive age
Treatment:
Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms

Trial contacts and locations

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Central trial contact

Simone Ferrero, MD; Fabio Barra

Data sourced from clinicaltrials.gov

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