Lynch SyndromeNCT05909410
Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
An observational study of Lynch Syndrome and Contraception, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome, Contraception
- What is being tested?
- Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with certain genetic diagnosis of Lynch syndrome and of reproductive age undergoing routinely gynecological visit
Who may be able to join
- patients with certain genetic diagnosis of Lynch syndrome and patients of reproductive age undergoing routinely gynecological visit
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Simone Ferrero, simone.ferrero@me.com
About this study
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.
- Conditions
- Lynch Syndrome, Contraception
- Being tested
- Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
- Keywords
- Lynch syndrome
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptomsOther
This survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms
| Study group | Role | What they receive |
|---|---|---|
| Patients with Lynch syndrome | Certain genetic diagnosis o fLynch syndrome Receives: Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms | |
| Healthy patients of reproductive age | Not described Receives: Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients using currently CHCs
Evaluation of the number (%) of patients using currently CHCs
Measured: Through study completion, an average of 1 month
Number of patients having used CHCs
Evaluation of the number (%) of patients having used CHCs in the past
Measured: Through study completion, an average of 1 month
Perception about the impact of CHCs on favoring/contrasting specific cancer onset
By using a Likert scale (from -5 to +5)
Measured: Through study completion, an average of 1 month
Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset
By using a Likert scale (from -5 to +5)
Measured: Through study completion, an average of 1 month
Perception about the impact of CHCs on favoring/contrasting specific symptoms onset
By using a Likert scale (from -5 to +5)
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Investigators
- Simone Ferrero, Principal investigator, Piazza della Vittoria 14
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909410
- Sponsor's protocol ID
- HORMONES-LYNCH
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35946412Grandi 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.
PubMed 34002428Grandi 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.
PubMed 34124968Barra F, Perrone U, Ferrero S, Bogliolo S, Ottonello S, Gustavino C, Iasci A, Grandi G, Pulliero A, Centurioni MG, Izzotti A. Perception about benefits and risks related to combined hormonal contraceptives use in women with Lynch syndrome. Ann Med. 2024 Dec;56(1):2370568. doi: 10.1080/07853890.2024.2370568. Epub 2024 Jun 26.
PubMed 38920120
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
- ClinicalTrials.gov ID
- NCT05909410
- Acronym / sponsor ID
- HORMONES-LYNCH
- Conditions
- Lynch Syndrome, Contraception
- Keywords
- Lynch syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Lynch syndrome | – | Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptomsCertain genetic diagnosis o fLynch syndrome |
| Healthy patients of reproductive age | – | Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with certain genetic diagnosis of Lynch syndrome and of reproductive age undergoing routinely gynecological visit
Key inclusion criteria (1 listed)
- patients with certain genetic diagnosis of Lynch syndrome and patients of reproductive age undergoing routinely gynecological visit
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptomsThis survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms | Other | Healthy patients of reproductive age, Patients with Lynch syndrome |
Primary outcome
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
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
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 35946412Grandi 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.
- Background: PubMed 34002428Grandi 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.
- Background: PubMed 34124968Grandi 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.
- Derived from this study: PubMed 38920120Barra F, Perrone U, Ferrero S, Bogliolo S, Ottonello S, Gustavino C, Iasci A, Grandi G, Pulliero A, Centurioni MG, Izzotti A. Perception about benefits and risks related to combined hormonal contraceptives use in women with Lynch syndrome. Ann Med. 2024 Dec;56(1):2370568. doi: 10.1080/07853890.2024.2370568. Epub 2024 Jun 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Ferrero principal investigator
Piazza della Vittoria 14
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome and Contraception, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Ferrero, MD (01139 010 511525, simoneferrero@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients using currently CHCs (time frame: Through study completion, an average of 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909410, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.