Breast Cancer, Omics, and Precision Medicine (BR(E)2ASTOME)
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ClinicalTrials.gov Identifier: NCT04996836 |
Recruitment Status : Unknown
Verified August 2021 by Giuditta Benincasa, University of Campania "Luigi Vanvitelli".
Recruitment status was: Not yet recruiting
First Posted : August 9, 2021
Last Update Posted : August 13, 2021
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Biological: Next Generation Sequencing and Network Analysis | Phase 2 |
The BR(E)2ASTOME study will be performed at the U.O.C. Patologia Molecolare e Clinica, University of Campania "L. Vanvitelli", Naples (Italy) with a long-standing experience in diagnosis and treatment of BC (Refs.). From each study participant, total of 10 mL of pheripheral blood in EDTA tubes will be collected at time of BC diagnosis. Blood-based assays will be performed to obtain genetic and/or epigenetic big data from ct-DNA and gDNA, respectively. A network-oriented algorithm combined with patient-level clinical information will be applied to big data in order to identify clusters of genes (BC-modules) harboring novel genetic mutations, in the NGS-ctDNA BC-group, and differentially methylated regions (DMRs), in the RRBS-gDNA group, with a potential predictive and prognostic role in BC management. In the NGS-ctDNA-RRBS-gDNA group, we will evaluate whether the multi-omics approach is more informative as compared to the single-omic paradigm.
BC patients (males and females) will be randomized to the 2 study arms: ctDNA-NGS + gDNA-RRBS, and standard of care alone. No modifications of intervention assignment will be possible after randomization process of patients. The BR(E)2ASTOME study will provide evidence about the potential clinical utility of early use liquid-based assays and network-oriented biomarkers in prognosis and prediction of drug response in BC management.
Thus, results from BR(E)2ASTOME study will bring to identify not only new molecular mechanisms associated with BC, but also non-invasive biomarkers that can direct towards an early diagnosis, contribute to monitor the cancer progression and the response to therapeutic treatment.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Other |
Official Title: | Evaluating the Predictive and Prognostic Power of the Early Breast canceR gEnetic and Epigenetic Abnormalities Through Liquid biopSy and neTwOrk MEdicine Algorithm: the BR(E)2ASTOME Phase II Randomized Controlled Trial |
Estimated Study Start Date : | January 2022 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
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Experimental: BC diagnosis and Omics
Participants will be offered:
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Biological: Next Generation Sequencing and Network Analysis
Next Generation Sequencing and Network Analysis will profile genetic and epigenetic abnormalities in blood from patients with BC. |
No Intervention: BC diagnosis and standard of the care
Participants will not be offered targeted NGS or whole-genome RRBS but will receive their usual clinical care
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- Evaluation of Network-oriented buomarkers in prognosis of BC [ Time Frame: 1 years ]
We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for a better stratification of BC severity.
We will measure:
DNA methylation levels and associations with clinical parameters (survival, hospitalization, all-cause mortality).
We will evaluate potential novel genetic mutations in targeted genes and associations with clinical parameters (survival, rate of hospitalization, all-cause mortality)
- Evaluation of Network-oriented buomarkers of Drug Response [ Time Frame: 2 years ]
We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for predicting the individual drug response.
We will measure DNA methylation levels, and potential novel genetic mutations, and their association with clinical parameters (poor/good response to drug therapy).
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sporadic BC
- Inherited BC
- 18 years old
- Males and Females
Exclusion Criteria:
- Inflammatory diseases
- Cardiovascular diseases
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): NCT04996836
Contact: Giuditta Benincasa, PhD | +390815667916 | giuditta.benincasa@unicampania.it |
Responsible Party: | Giuditta Benincasa, Principal Investigator, University of Campania "Luigi Vanvitelli" |
ClinicalTrials.gov Identifier: | NCT04996836 |
Other Study ID Numbers: |
LV |
First Posted: | August 9, 2021 Key Record Dates |
Last Update Posted: | August 13, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liquid biopsy DNA methylation Omics |
Biomarkers Network Analysis Precision Medicine |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |