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The Andromeda Study.Predictive Value of Combined Criteria to Tailor Breast Cancer Screening.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618538
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Azienda Sanitaria Locale di Biella
Azienda Sanitaria Locale di Vercelli
Fondazione Edo Ed Elvo Tempia Valenta
Associazione Italiana per la Ricerca sul Cancro
Information provided by (Responsible Party):
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

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.

Condition or disease
Breast Cancer

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 26600 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Predictive Value of Combined Criteria to Tailor Breast Cancer Screening and New Opportunities From Circulating Markers. The Andromeda Study.
Study Start Date : July 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. PPV (Positive Predictive Value) of BC risk factors [ Time Frame: 2 years ]
    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 Outcome Measures :
  1. Circulating biomarkers association with breast cancer [ Time Frame: 2 years ]
    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.


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   46 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618538


Locations
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Italy
Senologia Di Screening - Sscvd
Torino, Piedmont Region, Italy, 10126
S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino
Torino, Piedmont, Italy, 10123
ASL Biella
Biella, Italy, 13876
ASL Vercelli
Vercelli, Italy, 13100
Sponsors and Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Azienda Sanitaria Locale di Biella
Azienda Sanitaria Locale di Vercelli
Fondazione Edo Ed Elvo Tempia Valenta
Associazione Italiana per la Ricerca sul Cancro
Investigators
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Principal Investigator: Nereo Segnan, MD MSc Epi Structure director
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
ClinicalTrials.gov Identifier: NCT02618538    
Other Study ID Numbers: Progetto IG 2014 Id.15374
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: February 2018
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases