Clinical trial · Observational
The Andromeda Study.Predictive Value of Combined Criteria to Tailor Breast Cancer Screening.
Predictive Value of Combined Criteria to Tailor Breast Cancer Screening and New Opportunities From Circulating Markers. The Andromeda Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PPV (Positive Predictive Value) of BC risk factors
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (1)
- measure
- Circulating biomarkers association with breast cancer
- timeFrame
- 2 years
- description
- investigate whether selected circulating miRNAs previously found associated to BC risk are significantly altered in the plasma of cancer patients compared to matched healthy controls and if they satisfy pre-specified true- and false-positive rates that are considered minimally acceptable in the screening setting.
Eligibility
Eligibility (as posted)
- Minimum age
- 46 Years
- Maximum age
- 67 Years
Show eligibility criteria text
Inclusion Criteria: * All women undergoing a screening mammography in the participating centers. Exclusion Criteria: * Women unable to give informed consent
References
Publications (11)
- BACKGROUNDGiorgi 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 23293268
- BACKGROUNDSchousboe 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 21727289
- BACKGROUNDVilaprinyo 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 24498285
- BACKGROUNDNg 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 23301032
- BACKGROUNDGodfrey 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 23705859
- BACKGROUNDWu 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 22387599
- BACKGROUNDPetracci 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.