NCT02618538

Brief Summary

Some women have a higher risk than others of developing breast cancer. Unhealthy lifestyles, high breast density, family history, obesity, the presence of biomarkers associated with early neoplastic changes (considered alone or in combination) are just some of main factors that can increase the risk of breast cancer. Women with a higher risk may need to undergo more intensive screening activities, which include more frequent inspections and the possibility of experiment different types of tests. Instead, low risk women could be screened at longer intervals in order to reduce the screening harms (false positive results, overdiagnosis, radiation exposure, discomfort caused by the test itself, etc.) The ANDROMEDA Study aims at creating the possibility to customize the screening paths through a combined analysis of the above mentioned risk factors. Women consenting to be involved in the study will be asked to provide information on their lifestyle habits and reproductive history. Furthermore a blood sample will be collected for further bio-molecular analysis purposes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 23, 2019

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

November 27, 2015

Last Update Submit

July 22, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PPV (Positive Predictive Value) of BC risk factors

    The primary outcome measure is to estimate in a large cohort of women attending BC screening, the predictive positive values of different BC risk factors (alone or in combination) in order to identify appropriate risk-based stratifications for personalised screening.

    2 years

Secondary Outcomes (1)

  • Circulating biomarkers association with breast cancer

    2 years

Eligibility Criteria

Age46 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women aged 46-67 years and resident in Turin, Vercelli, and Biella (the three screening centres involved in the study) and invited to perform a screening mammography.

You may qualify if:

  • All women undergoing a screening mammography in the participating centers.

You may not qualify if:

  • Women unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino

Turin, Piedmont, 10123, Italy

Location

Senologia Di Screening - Sscvd

Turin, Piedmont, 10126, Italy

Location

ASL Biella

Biella, 13876, Italy

Location

ASL Vercelli

Vercelli, 13100, Italy

Location

Related Publications (11)

  • Giorgi D, Giordano L, Ventura L, Frigerio A, Paci E, Zappa M. [Mammography breast cancer screening in Italy: 2010 survey]. Epidemiol Prev. 2012 Nov-Dec;36(6 Suppl 1):8-27. Italian.

    PMID: 23293268BACKGROUND

  • Schousboe JT, Kerlikowske K, Loh A, Cummings SR. Personalizing mammography by breast density and other risk factors for breast cancer: analysis of health benefits and cost-effectiveness. Ann Intern Med. 2011 Jul 5;155(1):10-20. doi: 10.7326/0003-4819-155-1-201107050-00003.

    PMID: 21727289BACKGROUND

  • Vilaprinyo E, Forne C, Carles M, Sala M, Pla R, Castells X, Domingo L, Rue M; Interval Cancer (INCA) Study Group. Cost-effectiveness and harm-benefit analyses of risk-based screening strategies for breast cancer. PLoS One. 2014 Feb 3;9(2):e86858. doi: 10.1371/journal.pone.0086858. eCollection 2014.

    PMID: 24498285BACKGROUND

  • Ng EK, Li R, Shin VY, Jin HC, Leung CP, Ma ES, Pang R, Chua D, Chu KM, Law WL, Law SY, Poon RT, Kwong A. Circulating microRNAs as specific biomarkers for breast cancer detection. PLoS One. 2013;8(1):e53141. doi: 10.1371/journal.pone.0053141. Epub 2013 Jan 3.

    PMID: 23301032BACKGROUND

  • Godfrey AC, Xu Z, Weinberg CR, Getts RC, Wade PA, DeRoo LA, Sandler DP, Taylor JA. Serum microRNA expression as an early marker for breast cancer risk in prospectively collected samples from the Sister Study cohort. Breast Cancer Res. 2013 May 24;15(3):R42. doi: 10.1186/bcr3428.

    PMID: 23705859BACKGROUND

  • Wu Q, Wang C, Lu Z, Guo L, Ge Q. Analysis of serum genome-wide microRNAs for breast cancer detection. Clin Chim Acta. 2012 Jul 11;413(13-14):1058-65. doi: 10.1016/j.cca.2012.02.016. Epub 2012 Feb 23.

    PMID: 22387599BACKGROUND

  • Petracci E, Decarli A, Schairer C, Pfeiffer RM, Pee D, Masala G, Palli D, Gail MH. Risk factor modification and projections of absolute breast cancer risk. J Natl Cancer Inst. 2011 Jul 6;103(13):1037-48. doi: 10.1093/jnci/djr172. Epub 2011 Jun 24.

    PMID: 21705679BACKGROUND

  • Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter JD. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design. J Natl Cancer Inst. 2008 Oct 15;100(20):1432-8. doi: 10.1093/jnci/djn326. Epub 2008 Oct 7.

    PMID: 18840817BACKGROUND

  • Sozzi G, Boeri M, Rossi M, Verri C, Suatoni P, Bravi F, Roz L, Conte D, Grassi M, Sverzellati N, Marchiano A, Negri E, La Vecchia C, Pastorino U. Clinical utility of a plasma-based miRNA signature classifier within computed tomography lung cancer screening: a correlative MILD trial study. J Clin Oncol. 2014 Mar 10;32(8):768-73. doi: 10.1200/JCO.2013.50.4357. Epub 2014 Jan 13.

    PMID: 24419137BACKGROUND

  • Chiorino G, Petracci E, Sehovic E, Gregnanin I, Camussi E, Mello-Grand M, Ostano P, Riggi E, Vergini V, Russo A, Berrino E, Ortale A, Garena F, Venesio T, Gallo F, Favettini E, Frigerio A, Matullo G, Segnan N, Giordano L. Plasma microRNA ratios associated with breast cancer detection in a nested case-control study from a mammography screening cohort. Sci Rep. 2023 Jul 25;13(1):12040. doi: 10.1038/s41598-023-38886-0.

    PMID: 37491482DERIVED

  • Giordano L, Gallo F, Petracci E, Chiorino G, Segnan N; Andromeda working group. The ANDROMEDA prospective cohort study: predictive value of combined criteria to tailor breast cancer screening and new opportunities from circulating markers: study protocol. BMC Cancer. 2017 Nov 22;17(1):785. doi: 10.1186/s12885-017-3784-5.

    PMID: 29166878DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nereo Segnan, MD MSc Epi

    Structure director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 1, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 23, 2019

Record last verified: 2018-02

Locations

IT(4)