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

NCT04590560 | Recruiting

• 1 other identifier: IRST174.22
• Study Type: interventional
• Target: 60,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

Breast cancer, screening, diagnosis, mammography

Outcome Measures

Primary Outcomes (1)

• To compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals

  Cumulative breast cancer risk will computed as the ratio between the number of stage 2 or higher cancers and the total number of women in the arm. The comparison between arms will be performed using the two proportion Z-test. 95% confidence intervals will also be computed

  6 years

Secondary Outcomes (9)

• Participation in screening

  6 years

• contamination proportion (use of mammography) within two screening rounds (in women referred to 2-year interval)

  6 years

• Breast cancer detection

  6 years

• overall recall rate

  6 years

• rate of recall with an invasive procedure (biopsy)

  6 years

Study Arms (3)

1-year screening interval

NO INTERVENTION

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

2-year screening interval

EXPERIMENTAL

Women will be invited to screen every two years

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

3-tailored screening interval

EXPERIMENTAL

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)

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

Interventions

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

2-year screening interval; 3-tailored screening interval

Eligibility Criteria

• Age: 45 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women invited for their first or second mammography (45 or 46 y/o) presenting for screening;
• Willingness and ability to comply with scheduled visits;
• Written informed consent obtained prior to performing any protocol-related procedures.

You may not qualify if:

• Pregnancy status;
• Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;
• Ascertained heredo-familial risk according to the standard family history used in screening programs;
• Participation in another clinical trial on BC screening;
• Inability to provide signed informed consent.

Sponsors & Collaborators

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

Study Sites (4)

Irst Irccs

Meldola (FC), FC, 47014, 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

MeSH Terms

Conditions

Breast Neoplasms; Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Fabio Falcini, MD

  IRST IRCCS

  STUDY CHAIR

• Livia Giordano, MD

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

  PRINCIPAL INVESTIGATOR

• Marco Zappa, MD

  ISPRO Firenze

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriana Nanni

CONTACT

+39 0543 739100; oriana.nanni@irst.emr.it

Chiara Zingaretti

CONTACT

cc.ubsc@irst.emr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: February 6, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)