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AzTrials

Advanced/Metastatic Breast CancerPRAEGNANTNCT02338167

Praegnant Breast Cancer: Early/Advanced/Metastatic

An observational study of Advanced/Metastatic Breast Cancer and Breast Cancer (Early Breast Cancer), run by University Hospital Tuebingen at 61 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Blood sampling
Type of treatment
Surgery or procedure
How many people
13,500 participants
Where
61 sitesGermany
Study dates
Jun 2014to Jul 2030
How long will I take part?
60 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen. 3500 patients with locally advanced/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line). A patient can only participate after providing informed consent.

Who may be able to join

  • Adult breast cancer patients (age ≥18 years)
  • Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry
  • Patients, who are able and willing to sign the informed consent form
  • Adult women aged ≥18 years
  • Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to "non-invasive"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and
  • Patients, who are willing and able to sign the informed consent form
  • Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)

Who cannot join

  • Patients who did not sign the informed consent form
  • Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician

Trial locations and contacts

61 sites in 1 country. Contact the study team or a site near you to ask about taking part.

61 sites in 1 country

Germany61 sites, 52 recruiting
  • Uniklinik RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

    Recruiting
  • Gesundheitszentrum St. Marien GmbH

    Amberg, Bavaria, 92224

    Recruiting
  • Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken

    Ansbach, Bavaria, 91522

    Recruiting
  • Hämatologische-onkologische Praxis

    Augsburg, Bavaria, 86150

    Completed
  • Klinikum Augsburg

    Augsburg, Bavaria, 86156

    Recruiting
  • Sozialstiftung Bamberg Klinikum am Bruderwald

    Bamberg, Bavaria, 96049

    Recruiting
  • Klinikum Bayreuth

    Bayreuth, Bavaria, 95445

    Recruiting
  • Charité

    Berlin, State of Berlin, 10117

    Completed
  • MediOnko-Institut GbR

    Berlin, State of Berlin, 10367

    Recruiting
  • Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken

    Berlin, State of Berlin, 13125

    Recruiting
  • Klinikum Sindelfingen-Böblingen gGmbH

    Böblingen, Baden-Wurttemberg, 71032

    Recruiting
  • Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn

    Bonn, North Rhine-Westphalia, 53111

    Recruiting
  • Marienhospital

    Bottrop, North Rhine-Westphalia, 46236

    Recruiting
  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

    Recruiting
  • Klinikum Darmstadt Frauenklinik

    Darmstadt, Hesse, 64283

    Recruiting
  • DONAUISAR Klinikum

    Deggendorf, Bavaria, 94469

    Recruiting
  • Onkologisches Zentrum Donauwörth

    Donauwörth, Bavaria, 86609

    Recruiting
  • Universitätsklinik Dresden

    Dresden, Saxony, 01307

    Recruiting
  • Universitätsfrauenklinik Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

    Recruiting
  • Rottal-Inn-Kliniken GmbH

    Eggenfelden, Bavaria, 84307

    Recruiting
  • Universitätsfrauenklinik Erlangen

    Erlangen, Bavaria, 91012

    Recruiting
  • Kliniken Essen-Mitte

    Essen, North Rhine-Westphalia, 45136

    Completed
  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, Hesse, 60389

    Recruiting
  • Klinik für Frauenheilkunde, Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Recruiting
  • Praxis für Frauenheilkunde und Geburtshilfe

    Fürstenwalde, Brandenburg, 015517

    Recruiting
  • Klinikum Fürth

    Fürth, Bavaria, 90766

    Recruiting
  • Niels-Stensen-Kliniken

    Georgsmarienhütte, Lower Saxony, 49124

    Recruiting
  • Universitätsklinikum Halle (Saale)

    Halle, Saxony-Anhalt, 06120

    Recruiting
  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Recruiting
  • Onkologie Lerchenfeld

    Hamburg, Free and Hanseatic City of Hamburg, 22081

    Completed
  • NCT Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Recruiting
  • Study site

    Herne, North Rhine-Westphalia, 44623

    Completed
  • MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie

    Hösbach, Bavaria, 63768

    Recruiting
  • Schwerpunktpraxis für Hämatologie und Onkologie

    Kaiserslautern, Rhineland-Palatinate, 67655

    Recruiting
  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76135

    Recruiting
  • Klinikum Kassel GmbH

    Kassel, Hesse, 34125

    Recruiting
  • Klinik für Gynäkologie und Geburtshilfe

    Kiel, Schleswig-Holstein, 24105

    Completed
  • Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, North Rhine-Westphalia, 56068

    Recruiting
  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen, Hesse, 63225

    Recruiting
  • Onkologische Schwerpunktpraxis Leer-Emden

    Leer, Lower Saxony, 26789

    Recruiting
  • Universitäres Krebszentrum Leipzig

    Leipzig, Saxony, 04103

    Recruiting
  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

    Recruiting
  • Praxisklinik am Rosengarten

    Mannheim, Baden-Wurttemberg, 68165

    Recruiting
  • Institut für Versorgungsforschung

    Mayen, Rhineland-Palatinate, 56727

    Recruiting
  • Onkologie Elisenhof, München

    München, Bavaria, 80335

    Completed
  • Klinikum der Universität München Frauenklinik

    München, Bavaria, 81337

    Recruiting
  • Frauenklinik und Poliklinik der Technischen Universität München

    München, Bavaria, 81675

    Recruiting
  • Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg

    Neuruppin, Brandenburg, 16816

    Recruiting
  • medius Klinik Nürtingen

    Nürtingen, Baden-Wurttemberg, 72622

    Recruiting
  • medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit

    Ostfildern, 73760

    Recruiting
  • St. Vincenz-Krankenhaus GmbH

    Paderborn, North Rhine-Westphalia, 33098

    Recruiting
  • Praxis Onkologie und Hämatologie

    Recklinghausen, North Rhine-Westphalia, 45657

    Completed
  • Caritas-Krankenhaus St. Josef

    Regensburg, Bavaria, 93053

    Recruiting
  • Immanuel Klinik und Poliklinik Rüdersdorf GmbH

    Rüdersdorf, Brandenburg, 15562

    Recruiting
  • g.SUND Gynäkologie Kompetenzzentrum Stralsund

    Stralsund, Mecklenburg-Vorpommern, 18435

    Recruiting
  • Kreiskrankenhaus Torgau

    Torgau, Saxony, 04860

    Recruiting
  • Universitätsfrauenklinik Tübingen

    Tübingen, Baden-Wurttemberg

    Recruiting
  • Universitätsfrauenklinik Ulm

    Ulm, Baden-Wurttemberg, 89081

    Recruiting
  • Lahn-Dill-Kliniken GmbH Klinikum Wetzlar

    Wetzlar, Hesse, 35578

    Completed
  • Gesellschaft für Medizinische Studien Würselen

    Würselen, North Rhine-Westphalia, 52146

    Recruiting
  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Recruiting

Other trials in Germany

About this study

Official title: Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced/Metastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics

Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge.

Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected.

Read more

However molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare.

With modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor.

Furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.

Being tested
Blood sampling
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingProcedure or surgery

    A blood sample will be taken during a routine blood draw

Study groups in NCT02338167
Study groupRoleWhat they receive
Advanced/metastatic breast cancer3,500 patients with locally advanced, inoperable/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line).
Receives: Procedure: Blood sampling
Early breast cancer10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen.
Receives: Procedure: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)

    Analyses will be done separately for each therapy line. Biomarkers include gene expression profiling of the primary tumor and the corresponding metastases, somatic mutations, germline genetic variation, epigenetic changes and miRNA variation up to a total of 500,000 biomarkers.

    Measured: PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry

  2. EBC (Early Breast Cancer): Assessment of disease free sur-vival (DFS)

    DFS defined as the time to the first disease recurrence after study inclusion from time of primary diagnosis before or at study entry

    Measured: up to 60 months

Secondary outcomes (24)
  1. MBC: Assessment of overall survival (OS)

    OS is defined as the time to death from the date of the last progression before or at study entry.

    Measured: OS is defined as the time to death from the date of the last progression before or at study entry.

  2. MBC: Assessment of breast cancer specific survival (BCSS)

    BCSS is defined as the time to to death due to breast cancer from the date of the last progression before or at study entry.

    Measured: Time to death from the date of the last progression before or at study entry.

  3. MBC: Objective response

    Objective response is defined as the best-documented response to the therapy started at study entry or the last therapy started before study entry.

    Measured: up to 60 months

  4. MBC: Description of therapies used in the metastatic setting

    Therapies will be categorized and descriptive statistics will be presented.

    Measured: after 60 months (after study completion)

  5. MBC: Quality of life

    Assessed with EORTC QlQ-C30 and Visual Analog Scala

    Measured: Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  6. MBC: Therapy adherence

    Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect.

    Measured: up to 60 months

  7. MBC: Influencing Factors of Depression in patients with metastatic breast cancer

    Depression will be assessed by patient reported questionnaires e.g. CESD-R.

    Measured: Study entry and every 3 month or following a change of a therapy line (event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  8. MBC: Incidence of adverse events, serious adverse events will be reported.

    According to NCI Common Toxicity Criteria Version 4.03.

    Measured: up to 60 months

  9. MBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial.

    Number of patients who will receive molecular testing results compared to the total number of included patients.

    Measured: Once at end of study

  10. MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)

    Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.

    Measured: Once at end of study

  11. MBC: Health economics for women with metastatic and/or locally advanced, inoperable breast cancer.

    EORTC QLQ C-30 (Version 3.0) (among others) and actu-al documented costs of diagnostic procedures, therapies, treatment of side effects and care for tumor-associated symptoms will be used to calculate health care costs, quality adjusted life years (QALY) and incremental cost effectiveness ratios (ICER) between patient groups.

    Measured: Study entry and every 3 month or following a change of a therapy line (event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  12. MBC: Patient reported influencing factors on therapy adherence in patients metastatic and/or locally advanced, inoperable breast cancer.

    Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.

    Measured: Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  13. EBC: Assessment of distant disease-free survival (DDFS)

    DDFS defined as the time to the first distant disease recurrence after study inclusion from time of primary diagnosis before or at study entry.

    Measured: Up to 60 months

  14. EBC: Quality of life

    Assessed with EORTC QLQ C-30 (Version 3.0), EORTC QLQ-BR23 and the EQ-Visual Analog Scale (VAS)

    Measured: Study entry and every 3 month or following a change of a therapy line (event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  15. EBC: Assessment of overall survival (OS)

    OS is defined as the time to death from the date of the primary diagnosis before or at study entry.

    Measured: OS is defined as the time to death from the date of the last progression before or at study entry.

  16. EBC: Assessment of breast cancer specific survival (BCSS)

    BCSS is defined as the time to death due to breast cancer from the date of the primary diagnosis before or at study entry.

    Measured: Time to death due to breast cancer from the date of the primary diagnosis before or at study entry.

  17. EBC: Description of therapies used in the early breast cancer setting

    Therapies will be categorized, and descriptive statistics will be presented.

    Measured: after 60 months (after study completion)

  18. EBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial.

    Number of patients who will receive molecular testing results compared to the total number of included pa-tients.

    Measured: Once at end of study

  19. EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)

    Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.

    Measured: Once at end of study

  20. EBC: Therapy adherence

    Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect

    Measured: up to 60 months

  21. EBC: Health economics for women with breast cancer

    EORTC QLQ C-30 (Version 3.0) (among others) and actu-al documented costs of diagnostic procedures, thera-pies, treatment of side effects and care for tumor-associated symptoms will be used to calculate health care costs, quality adjusted life years (QALY) and incre-mental cost effectiveness ratios (ICER) between patient groups.

    Measured: up to 60 months

  22. EBC: Influencing Factors of Depression in patients with breast cancer

    Depression will be assessed by patient reported ques-tionnaires e.g. CESD-R.

    Measured: Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  23. EBC: Patient reported influencing factors on therapy adherence in patients with early breast cancer.

    Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.

    Measured: Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

  24. EBC: Incidence of adverse events, serious ad-verse events will be reported.

    NCI Common Toxicity Criteria Version 4.03.

    Measured: up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
13,500 participants (estimated)
Target duration
60 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02338167
Sponsor's protocol ID
SEN-01/14
Acronym
PRAEGNANT
Status last verified
Jan 2026
First submitted
9 Jan 2015
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Horner M, Tretschock LM, John N, Ziegler P, Haberle L, Uhrig S, Goossens C, Amann N, Cieslik JP, Dannehl D, Deutsch TM, Dimpfl M, Ehlert M, Eichstadt K, Englisch A, Kopke MB, Kruckel A, Link T, Muller A, Reinhardt K, Roth J, Schaffler H, Sych L, Tegeler CM, Wichmann C, Banys-Paluchowski M, Princk H, Rody A, Brucker SY, Ditsch N, Ettl J, Fehm T, Hack CC, Hadji P, Hein A, Janni WW, Kolberg HC, Luftner D, Lux MP, Muller V, Schneeweiss A, Taran FA, Tesch H, Wallwiener D, Marme F, Seitz S, Belleville E, Hartkopf A, Michel LL, Wallwiener M, Fasching PA, Tauber N. Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial. Breast Cancer Res Treat. 2026 Apr 2;217(1):9. doi: 10.1007/s10549-026-07939-z.

    PubMed 41925922
  • Muller V, Hein A, Hartkopf AD, Fasching PA, Kolberg HC, Hadji P, Tesch H, Haberle L, Ettl J, Luftner D, Wallwiener M, Beckmann MW, Schneeweiss A, Belleville E, Uhrig S, Wimberger P, Hielscher C, Meyer J, Wurmthaler LA, Kurbacher CM, Wuerstlein R, Untch M, Janni W, Taran FA, Lux MP, Wallwiener D, Brucker SY, Fehm TN, Michel LL. Occurrence and characteristics of patients with de novo advanced breast cancer according to patient and tumor characteristics - A retrospective analysis of a real world registry. Eur J Cancer. 2022 Sep;172:13-21. doi: 10.1016/j.ejca.2022.05.015. Epub 2022 Jun 18.

    PubMed 35728342
  • Hein A, Hartkopf AD, Emons J, Lux MP, Volz B, Taran FA, Overkamp F, Hadji P, Tesch H, Haberle L, Ettl J, Luftner D, Wurmthaler LA, Wallwiener M, Muller V, Beckmann MW, Belleville E, Wimberger P, Hielscher C, Kurbacher CM, Wuerstlein R, Thomssen C, Untch M, Fasching PA, Janni W, Fehm TN, Wallwiener D, Brucker SY, Schneeweiss A, Kolberg HC. Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status. Eur J Cancer. 2021 Sep;155:1-12. doi: 10.1016/j.ejca.2021.06.033. Epub 2021 Jul 23.

    PubMed 34311211
  • Huebner H, Kurbacher CM, Kuesters G, Hartkopf AD, Lux MP, Huober J, Volz B, Taran FA, Overkamp F, Tesch H, Haberle L, Luftner D, Wallwiener M, Muller V, Beckmann MW, Belleville E, Ruebner M, Untch M, Fasching PA, Janni W, Fehm TN, Kolberg HC, Wallwiener D, Brucker SY, Schneeweiss A, Ettl J. Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany. BMC Cancer. 2020 Nov 11;20(1):1091. doi: 10.1186/s12885-020-07546-1.

    PubMed 33176725

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced/Metastatic Breast Cancer and Breast Cancer (Early Breast Cancer), run by University Hospital Tuebingen at 61 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erik Belleville, PhD (+49 931 359200 ext. 36, belleville@clin-sol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS) (time frame: PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02338167, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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