- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992521
Breast Cancer Liquid Biopsy Stratification (BALIBISTRA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators collected 340 plasma samples from 144 clinically annotated patients with detailed clinical data. All plasma samples were already analyzed by plasma-Seq, an approach, which measures copy number from sequence read depth, for a first evaluation of somatic copy number alterations (SCNAs). As this project represents a feasibility study, the investigators want to evaluate to what extend cis-acting alterations can be determined, i.e. establish the corresponding gene expression changes via nucleosome position mapping as previously published by our group. The results will be corroborated by analyses of the corresponding primary tumor by SCNA-seq and RNA-seq.
From the 340 plasma samples the investigators selected 59 as representative for being either luminal (i.e. those with amplifications at 17q23, 11q13/q14, 8p12, 8q, and gains of 16p and 1q; n=25), basal (i.e. gains of 8q, 10p, 12p and various amplifications occurring due to the high-genomic instability; n=25), and ERBB2/HER2 (i.e. high-level amplification on 17q, centered and including the HER2 gene; n=9). These samples will be sequenced with high coverage (70x) so that both mutations and nucleosome positions can be extracted from the obtained sequences.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Graz, Austria, 8010
- Medical University of Graz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study includes women with proven histological diagnosis of breast cancer and appropriate clinical data.
Participants were recruited at the Medical University Hospital of Graz.
Description
Inclusion Criteria:
Histological diagnosis of breast cancer, availability of primary tumor tissue and plasma DNA with a high ctDNA content.
Exclusion Criteria:
Patient rejects the participation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluating as proof-of-concept the ability to stratify patients solely based on a detailed plasma DNA analysis
Time Frame: Three years
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Clinico-pathological characteristics including prior and subsequent therapies were recorded for each patient.
For each patient a standard classification into luminal, basal, ERBB2/HER2 was conducted and is available.
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Three years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael R Speicher, MD, Medical University of Graz
Publications and helpful links
General Publications
- Heitzer E, Haque IS, Roberts CES, Speicher MR. Current and future perspectives of liquid biopsies in genomics-driven oncology. Nat Rev Genet. 2019 Feb;20(2):71-88. doi: 10.1038/s41576-018-0071-5.
- Ulz P, Belic J, Graf R, Auer M, Lafer I, Fischereder K, Webersinke G, Pummer K, Augustin H, Pichler M, Hoefler G, Bauernhofer T, Geigl JB, Heitzer E, Speicher MR. Whole-genome plasma sequencing reveals focal amplifications as a driving force in metastatic prostate cancer. Nat Commun. 2016 Jun 22;7:12008. doi: 10.1038/ncomms12008.
- Ulz P, Heitzer E, Speicher MR. Co-occurrence of MYC amplification and TP53 mutations in human cancer. Nat Genet. 2016 Feb;48(2):104-6. doi: 10.1038/ng.3468. No abstract available.
- Ulz P, Thallinger GG, Auer M, Graf R, Kashofer K, Jahn SW, Abete L, Pristauz G, Petru E, Geigl JB, Heitzer E, Speicher MR. Inferring expressed genes by whole-genome sequencing of plasma DNA. Nat Genet. 2016 Oct;48(10):1273-8. doi: 10.1038/ng.3648. Epub 2016 Aug 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BreastctDNA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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