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What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?

NCT ID: NCT04590560

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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According to the 2006 European guidelines, the target age for mammography screening is 50-69 years. For women aged 40-49, effectiveness is less and less certain. For those over 70, the most important concern is overdiagnosis. In Europe, so far, both age groups have been invited to screen only in a few countries and regional areas, including some Italian regions. Recently, new European guidelines have been published, developed in the framework of the European Commission Initiative on Breast Cancer. Although with caution, they recommend screening for both women aged 45-49 and those aged 70-74. The recommended interval is 2 or 3 years in the first case and 3 years in the second. The quality of the evidence on which these recommendations are based is defined as very low. Particularly for women aged 45-49, the new European guidelines indicate the need for a research effort, based on comparative studies, on the effectiveness of different screening intervals. This responsibility also falls on Italy, which is the only European country where women aged 45-49 are invited on an annual basis. Therefore, a research project is proposed which 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.

To define the best interval for screening women 45-49 years old a three-arm multicenter randomized non-inferiority trial will be conducted. Women signing the written informed consent will be randomized with a 1:1:1 ratio to:

Arm 1: 1-year screening interval; Arm 2: 2-year screening interval; Arm 3: tailored screening interval on the basis of breast density. Women with very dense breast (Breast Imaging-Reporting and Data System -BI-RADS- category D) will be referred to 1-year interval whereas women with less dense breast to 2-year interval (Breast Imaging-Reporting and Data System -BI-RADS- category A, B, C).

Enrollment will last 2.5 years and all women will be followed for 6 years. 60,000 women will be enrolled.

The primary objective is to compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals and this will be evaluated at the end of the 6-year follow-up period.

At the same time, data from all women registered in screening archives who have had a negative mammogram at the age of 69-71 years will be collected and analyzed. The data will be retrieved up to the age of 78 and will concern screening mammograms as well as other screening procedures (e.g. biopsies) and also mammograms performed outside the program. Data from screening and outpatient information systems as well as from cancer registries will be used.

To identify the best strategy to communicate changes in screening protocols, especially when the new protocol would be less intensive than the actual one, a qualitative research will be conducted. In particular the following steps will be considered:

* Focus groups for discussing, with women from target population and health care professionals, key arguments identified in a preliminary research (i.e. scientific literature and case-studies research), with particular focus on how they should be translated into communication strategies.
* Pre-test of the study's communication material through web-based semi-structured interviews to eligible women and key-informants.
* Assessment of the effectiveness of the communication material through web-based semi-structured interviews to participants, that may bring insights on how planning communication strategies for the implementation of new screening protocols.

Conditions

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Breast Cancer

Keywords

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Breast cancer, screening, diagnosis, mammography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible women signing the written informed consent will be randomized with a 1:1:1 ratio to:

Arm 1: 1-year screening interval; Arm 2: 2-year screening interval; Arm 3: tailored screening interval on the basis of breast density. Women with very dense breast (BI-RADS category D) will be referred to 1-year interval whereas women with less dense breast to 2-year interval (BI-RADS category A, B, C).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1-year screening interval

Women will follow the normal screening program (they will be invited to screen every year)

Group Type NO_INTERVENTION

No interventions assigned to this group

2-year screening interval

Women will be invited to screen every two years

Group Type EXPERIMENTAL

screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice

Intervention Type DIAGNOSTIC_TEST

women will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;

3-tailored screening interval

the screening interval will be decided on the basis of breast density. Women with very dense breast (BI-RADS category D) will be referred to 1-year interval whereas women with less dense breast to 2-year interval (BI-RADS category A, B, C)

Group Type EXPERIMENTAL

screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice

Intervention Type DIAGNOSTIC_TEST

women will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;

Interventions

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screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice

women will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Falcini, MD

Role: STUDY_CHAIR

IRST IRCCS

Livia Giordano, MD

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Città della Salute e della Scienza

Marco Zappa, MD

Role: PRINCIPAL_INVESTIGATOR

ISPRO Firenze

Locations

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Irst Irccs

Meldola (FC), FC, Italy

Site Status RECRUITING

Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO)

Florence, , Italy

Site Status NOT_YET_RECRUITING

AUSL Romagna

Forlì, , Italy

Site Status RECRUITING

AOU Città della Salute e della Scienza

Torino, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Oriana Nanni

Role: CONTACT

Phone: +39 0543 739100

Email: [email protected]

Chiara Zingaretti

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fabio Falcini, MD

Role: primary

Marco Zappa, MD

Role: primary

Paola Mantellini, MD

Role: backup

Fabio Falcini, MD

Role: primary

Livia Giordano, MD

Role: primary

Other Identifiers

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IRST174.22

Identifier Type: -

Identifier Source: org_study_id