Clinical trial · Observational
Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Contraception | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with Lynch syndrome
- description
- Certain genetic diagnosis o fLynch syndrome
- interventionNames
- Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
- label
- Healthy patients of reproductive age
- interventionNames
- Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
Primary outcomes (5)
- measure
- Number of patients using currently CHCs
- timeFrame
- Through study completion, an average of 1 month
- description
- Evaluation of the number (%) of patients using currently CHCs
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 52 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDGrandi 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. PMID 35946412
- BACKGROUNDGrandi 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. PMID 34002428
- BACKGROUNDGrandi 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. PMID 34124968
- DERIVEDBarra 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. PMID 38920120