NCT04590560 What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?
| NCT ID | NCT04590560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60,000 participants |
| Start Date | 2020-02-06 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60,000 participants in total. It began in 2020-02-06 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
Eligibility 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.
Contact & Investigator
Fabio Falcini, MD
STUDY CHAIR
IRST IRCCS
Frequently Asked Questions
Who can join the NCT04590560 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 49 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04590560 currently recruiting?
Yes, NCT04590560 is actively recruiting participants. Contact the research team at oriana.nanni@irst.emr.it for enrollment information.
Where is the NCT04590560 trial being conducted?
This trial is being conducted at Meldola (FC), Italy, Florence, Italy, Forlì, Italy, Torino, Italy.
Who is sponsoring the NCT04590560 clinical trial?
NCT04590560 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. The principal investigator is Fabio Falcini, MD at IRST IRCCS. The trial plans to enroll 60,000 participants.
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