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Trial Title:
Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
NCT ID:
NCT05909410
Condition:
Lynch Syndrome
Contraception
Conditions: Official terms:
Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome
Conditions: Keywords:
Lynch syndrome
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
Description:
This survey investigated the CHC use (type and timing of administration) and patients'
perception about the relationship between CHC and cancer, diseases and symptoms
Arm group label:
Healthy patients of reproductive age
Arm group label:
Patients with Lynch syndrome
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.
Criteria for eligibility:
Study pop:
Patients with certain genetic diagnosis of Lynch syndrome and of reproductive age
undergoing routinely gynecological visit
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
female
Minimum age:
18 Years
Maximum age:
52 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
IRCCS Ospedale Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Contact:
Last name:
Simone Ferrero
Email:
simone.ferrero@me.com
Start date:
July 1, 2023
Completion date:
September 1, 2023
Lead sponsor:
Agency:
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Agency class:
Other
Source:
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05909410
