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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05909410
Enrollment
180
Registered
2023-06-18
Start date
2023-07-01
Completion date
2023-09-01
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Lynch Syndrome

Keywords

Lynch syndrome

Brief summary

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.

Interventions

OTHERSurvey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms

This survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms

Sponsors

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients using currently CHCsThrough study completion, an average of 1 monthEvaluation of the number (%) of patients using currently CHCs
Number of patients having used CHCsThrough study completion, an average of 1 monthEvaluation of the number (%) of patients having used CHCs in the past
Perception about the impact of CHCs on favoring/contrasting specific cancer onsetThrough study completion, an average of 1 monthBy using a Likert scale (from -5 to +5)
Perception about the impact of CHCs on favoring/contrasting specific chronic disease onsetThrough study completion, an average of 1 monthBy using a Likert scale (from -5 to +5)
Perception about the impact of CHCs on favoring/contrasting specific symptoms onsetThrough study completion, an average of 1 monthBy using a Likert scale (from -5 to +5)

Countries

Italy

Contacts

Primary ContactSimone Ferrero, MD
simoneferrero@me.com01139 010 511525
Backup ContactFabio Barra
fabio.barra@icloud.com0039 3349437959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026