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        <titl xml:lang="sv">Longitudinell multiomisk karakterisering av patientsvar på neoadjuvant HER2-riktad behandling</titl>
        <parTitl xml:lang="en">Longitudinal Multi-Omic Characterization of Patient Responses to Neoadjuvant HER2-Targeted Therapy</parTitl>
        <IDNo agency="SND">2026-179-1</IDNo>
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    <citation>
      <titlStmt>
        <titl xml:lang="sv">Longitudinell multiomisk karakterisering av patientsvar på neoadjuvant HER2-riktad behandling</titl>
        <parTitl xml:lang="en">Longitudinal Multi-Omic Characterization of Patient Responses to Neoadjuvant HER2-Targeted Therapy</parTitl>
        <IDNo agency="SND">2026-179-1</IDNo>
        <IDNo agency="DOI">https://doi.org/10.48723/js80-sx29</IDNo>
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        <AuthEnty xml:lang="en" affiliation="Department of Oncology-Pathology [K7], Karolinska Institutet">Wang, Kang</AuthEnty>
        <AuthEnty xml:lang="sv" affiliation="Institutionen för onkologi-patologi, Karolinska Institutet">Wang, Kang</AuthEnty>
        <AuthEnty xml:lang="en" affiliation="Department of Oncology-Pathology [K7], Karolinska Institutet">Sifakis, Emmanouil</AuthEnty>
        <AuthEnty xml:lang="sv" affiliation="Institutionen för onkologi-patologi, Karolinska Institutet">Sifakis, Emmanouil</AuthEnty>
        <AuthEnty xml:lang="en" affiliation="Department of Oncology-Pathology [K7], Karolinska Institutet">Foukakis, Theodoros</AuthEnty>
        <AuthEnty xml:lang="sv" affiliation="Institutionen för onkologi-patologi, Karolinska Institutet">Foukakis, Theodoros</AuthEnty>
      </rspStmt>
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        <grantNo xml:lang="en" agency="Swedish Research Council">2018-02398_VR</grantNo>
        <grantNo xml:lang="sv" agency="Vetenskapsrådet">2018-02398_VR</grantNo>
        <grantNo xml:lang="en" agency="Swedish Research Council">2021-03061_VR</grantNo>
        <grantNo xml:lang="sv" agency="Vetenskapsrådet">2021-03061_VR</grantNo>
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        <distrbtr xml:lang="en" abbr="SND" URI="https://snd.se">Swedish National Data Service</distrbtr>
        <distrbtr xml:lang="sv" abbr="SND" URI="https://snd.se">Svensk nationell datatjänst</distrbtr>
        <distDate xml:lang="en" date="2026-06-22" />
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    <stdyInfo>
      <subject>
        <keyword xml:lang="en" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D001943">Breast Neoplasms</keyword>
        <keyword xml:lang="sv" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D001943">Brösttumörer</keyword>
        <keyword xml:lang="en" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D018719">Receptor, ErbB-2</keyword>
        <keyword xml:lang="sv" vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D018719">ErbB-2-receptor</keyword>
      </subject>
      <abstract xml:lang="en" contentType="abstract">This dataset contains longitudinal multi-omic profiles derived from patients with early HER2-positive breast cancer enrolled in the randomized phase II PREDIX HER2 clinical trial (NCT02568839). The study compared neoadjuvant treatment with docetaxel, trastuzumab, and pertuzumab (DHP) versus trastuzumab emtansine (T-DM1). The primary aim of this data collection was to monitor tumor evolution and tumor microenvironment dynamics during HER2-targeted therapy.

Data Material and Collection:
The dataset comprises multi-omic data from patient samples collected at different timepoint: on-treatment (after two cycles of neoadjuvant therapy) and post-treatment (after six cycles of neoadjuvant therapy).

Methodology and Assay:
Comprehensive molecular characterization was performed using multiple high-throughput technologies. This includes whole-exome sequencing (WES) to identify somatic mutations and genomic alterations, RNA-sequencing (RNA-seq) for bulk transcriptomic profiling, and proteomics to monitor protein abundance. Additionally, imaging-based spatial transcriptomics was performed using the Xenium In Situ platform to map the spatial organization of the tumor microenvironment; note that the Xenium spatial data is exclusively available for the on-treatment time point.

The dataset consists of the following:
1) RNA-seq/sequencing_batch/Sample.fastq.gz
Folder containing raw paired-end FASTQ files from RNA-seq. 
Each tumor sample was multiplexed across sequencing sample/lane index combinations. 
File names begin with the project-sample ID and include R1 or R2, denoting forward and reverse reads, respectively.

2) WES/sequencing_batch/Sample.fastq.gz
Folder containing raw paired-end FASTQ files from RNA-seq. 
File names begin with the project-sample ID and include R1 or R2, denoting forward and reverse reads, respectively.

3) Xenium_5k
Each subfolder contains the standardized, uncompressed output directory generated by the Xenium Ranger analysis pipeline for an individual tissue section.

The entire dataset is over 10,000 files and over 10TB in size.</abstract>
      <abstract xml:lang="sv" contentType="abstract">Denna datauppsättning innehåller longitudinella multiomiska profiler härledda från patienter med tidig HER2-positiv bröstcancer som deltog i den randomiserade fas II-studien PREDIX HER2 (NCT02568839). Studien jämförde neoadjuvant behandling med docetaxel, trastuzumab och pertuzumab (DHP) jämfört med trastuzumab emtansin (T-DM1). Det primära syftet med denna datainsamling var att övervaka tumörutveckling och tumörmikromiljödynamik under HER2-riktad behandling.

Datamaterial och insamling:
Datumuppsättningen omfattar multiomiska data från patientprover som samlats in vid olika tidpunkter: under behandling (efter två cykler av neoadjuvant behandling) och efter behandling (efter sex cykler av neoadjuvant behandling).

Metod och analys:
Omfattande molekylär karakterisering utfördes med hjälp av flera högkapacitetstekniker. Detta inkluderar hel-exomsekvensering (WES) för att identifiera somatiska mutationer och genomiska förändringar, RNA-sekvensering (RNA-seq) för bulktranskriptomisk profilering och proteomik för att övervaka proteinmängd. Dessutom utfördes avbildningsbaserad spatial transkriptomik med hjälp av Xenium In Situ-plattformen för att kartlägga den rumsliga organisationen av tumörmikromiljön; observera att Xeniums rumsliga data exklusivt är tillgängliga för tidpunkten för behandling.</abstract>
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        <universe xml:lang="en">The research focuses on patients diagnosed with early HER2-positive breast cancer who were enrolled in the PREDIX HER2 randomized phase II clinical trial. The participants include women and men aged 18 years or older with HER2-positive tumors larger than 20 mm and/or lymph node metastases. Patients with oligometastatic disease (up to two distant metastases) were also eligible, provided all lesions could be radically treated locally. A total of 202 patients were enrolled, and the analysis specifically refers to the subset of patients who provided plasma samples for longitudinal proteomic profiling and tissue biopsies for multi-omics analysis.</universe>
        <universe xml:lang="sv">Forskningen fokuserar på patienter som diagnostiserats med tidig HER2-positiv bröstcancer och som deltog i den randomiserade fas II-studien PREDIX HER2. Deltagarna inkluderar kvinnor och män i åldern 18 år eller äldre med HER2-positiva tumörer större än 20 mm och/eller lymfkörtelmetastaser. Patienter med oligometastatisk sjukdom (upp till två fjärrmetastaser) var också berättigade, förutsatt att alla lesioner kunde behandlas radikalt lokalt. Totalt 202 patienter deltog, och analysen avser specifikt den delmängd av patienter som tillhandahöll plasmaprover för longitudinell proteomisk profilering och vävnadsbiopsier för multiomicsanalys.</universe>
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        <restrctn xml:lang="sv">Åtkomst till data via SND. Tillgång till data är begränsad.</restrctn>
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