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

NCT ID: NCT05909410

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lynch Syndrome Contraception

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Lynch syndrome

Certain genetic diagnosis o fLynch syndrome

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

Intervention Type OTHER

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

Healthy patients of reproductive age

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

Intervention Type OTHER

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

Interventions

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Survey 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

OTHER

Sponsor Role lead

Responsible Party

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Simone Ferrero

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Ferrero

Role: PRINCIPAL_INVESTIGATOR

Piazza della Vittoria 14

Locations

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IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Site Status

Countries

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Italy

Central Contacts

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Simone Ferrero, MD

Role: CONTACT

01139 010 511525

Fabio Barra

Role: CONTACT

0039 3349437959

Facility Contacts

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Simone Ferrero

Role: primary

References

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Grandi G, Monari F, Boggio Sola V, Cortesi L, Toss A, Del Savio MC, Melotti C, Centurioni MG, Gustavino C, Varesco L, Facchinetti F, Barra F. BRCA mutation carriers' perception about benefits and risks associated with combined hormonal contraceptives use. Eur J Contracept Reprod Health Care. 2022 Dec;27(6):439-444. doi: 10.1080/13625187.2022.2107199. Epub 2022 Aug 10.

Reference Type BACKGROUND
PMID: 35946412 (View on PubMed)

Grandi G, Boggio Sola V, Cortesi L, Toss A, Giuliani GA, Del Savio MC, Facchinetti F. BRCA mutation carriers' perceptions on postmenopausal hormone therapy: An Italian study. Psychooncology. 2021 Oct;30(10):1711-1719. doi: 10.1002/pon.5714. Epub 2021 May 28.

Reference Type BACKGROUND
PMID: 34002428 (View on PubMed)

Grandi G, Del Savio MC, Boggio Sola V, Monari F, Melotti C, Facchinetti F. Attitudes of women towards products containing hormones (hormonal contraceptives or hormone therapy): what changes from pre to postmenopause? Ann Med. 2021 Dec;53(1):908-915. doi: 10.1080/07853890.2021.1938662.

Reference Type BACKGROUND
PMID: 34124968 (View on PubMed)

Other Identifiers

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HORMONES-LYNCH

Identifier Type: -

Identifier Source: org_study_id

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