Determining the best screening interval for breast cancer in women aged 45-49 and 70-74
What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer
NA · Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT04590560
This study is trying to find the best timing for breast cancer screenings in women aged 45-49 and 70-74 to help improve recommendations for their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60000 (estimated) |
| Ages | 45 Years to 49 Years |
| Sex | Female |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS (other) |
| Locations | 4 sites (Meldola (FC), FC and 3 other locations) |
| Trial ID | NCT04590560 on ClinicalTrials.gov |
What this trial studies
This Italian multicenter project aims to identify the optimal screening intervals for breast cancer in women aged 45-49 and 70-74. It includes a controlled, prospective randomized non-inferiority trial for younger women, a retrospective analysis for older women, and qualitative research to enhance communication strategies. The study addresses the uncertainty surrounding the effectiveness of mammography screening in these age groups, particularly in light of recent European guidelines. By comparing different screening intervals, the research seeks to provide clearer recommendations for breast cancer screening practices.
Who should consider this trial
Good fit: Ideal candidates are women aged 45-49 or 70-74 who are invited for their first or second mammography screening.
Not a fit: Patients who are pregnant, have a personal history of breast cancer, or are at high hereditary risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective breast cancer screening protocols, potentially improving early detection and outcomes for women in these age groups.
How similar studies have performed: While there have been studies on breast cancer screening intervals, this particular approach focusing on these specific age groups and intervals is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women invited for their first or second mammography (45 or 46 y/o) presenting for screening; 2. Willingness and ability to comply with scheduled visits; 3. Written informed consent obtained prior to performing any protocol-related procedures. Exclusion Criteria: 1. Pregnancy status; 2. Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis; 3. Ascertained heredo-familial risk according to the standard family history used in screening programs; 4. Participation in another clinical trial on BC screening; 5. Inability to provide signed informed consent.
Where this trial is running
Meldola (FC), FC and 3 other locations
- Irst Irccs — Meldola (FC), FC, Italy (RECRUITING)
- Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO) — Florence, Italy (NOT_YET_RECRUITING)
- AUSL Romagna — Forlì, Italy (RECRUITING)
- AOU Città della Salute e della Scienza — Torino, Italy (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Livia Giordano, MD — A.O.U. Città della Salute e della Scienza
- Study coordinator: Oriana Nanni
- Email: oriana.nanni@irst.emr.it
- Phone: +39 0543 739100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast cancer, screening, diagnosis, mammography