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- Klinische proef NCT02591966
Genetic Alteration After Systemic Treatment in Breast Cancer
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.
The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:
- The patients who receive neoadjuvant systemic treatments:
- The patients who have distant metastatic sites at first and recur from surgery:
- The patients who are going to receive first-line chemotherapy
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van, 135-710
- Werving
- Samsung Medical Center
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Contact:
- Yeon Hee Park, MD, Ph.D
- Telefoonnummer: 82-2-3410-3459
- E-mail: yeonh.park@samsung.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
- The patients who receive neoadjuvant systemic treatments:
- The patients who have distant metastatic sites at first and recur from surgery:
- The patients who are going to receive first-line chemotherapy:
Beschrijving
Inclusion Criteria:
- Patients older than 20 years
Patients with histologically confirmed breast cancer at three disease status
- Patients who are going to receive neoadjuvant chemotherapy with feasible biopsy site.
- Patients who recur from curative surgery and have distant metastasis with feasible biopsy site. ; Patients must have received adjuvant chemotherapy after curative surgery.
- Patients who are going to first-line palliative chemotherapy with feasible biopsy site.
- Patients with PS ECOG 0 - 2
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- Written informed consent form
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to study as defined below:
- Haemoglobin ≥9.0 g/L (transfusion allowed)
- White blood cells (WBC) > 3 x 109/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
Exclusion Criteria:
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
- Double primary cancer (except for any cancer in remission for > 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Biomarker group
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Genomic profiling will be assessed by tissue sampling and blood.
Tijdsspanne: 2year
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Tissue and blood will be tested for CancerSCAN, cfDNA, WES, WTS, FACS, cytokine and immunologic signature analysis platform.NAC to study the multiscale relationships among DCE-MRI features, NGS data, and pathologic response to NAC and to evaluate the role of radiogenomics in predicting pathologic response of the patients.
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2year
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2014-11-015
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