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

June 8, 2023 updated by: Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Lynch syndrome
Certain genetic diagnosis o fLynch syndrome
Other: 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
Healthy patients of reproductive age
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients using currently CHCs
Time Frame: Through study completion, an average of 1 month
Evaluation of the number (%) of patients using currently CHCs
Through study completion, an average of 1 month
Number of patients having used CHCs
Time Frame: Through study completion, an average of 1 month
Evaluation of the number (%) of patients having used CHCs in the past
Through study completion, an average of 1 month
Perception about the impact of CHCs on favoring/contrasting specific cancer onset
Time Frame: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Through study completion, an average of 1 month
Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset
Time Frame: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Through study completion, an average of 1 month
Perception about the impact of CHCs on favoring/contrasting specific symptoms onset
Time Frame: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Investigators

  • Principal Investigator: Simone Ferrero, Piazza della Vittoria 14

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HORMONES-LYNCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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