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ID

45808

Beschreibung

Principal Investigator: Matthew Goetz, MD, Mayo Clinic, Rochester, MN, USA MeSH: Breast Neoplasms,Carcinoma, Ductal, Breast https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001050 The Breast Cancer Genome Guided Therapy Study (BEAUTY) is a prospective neoadjuvant clinical study enrolling 140 women with Stage I-III breast cancer. The goals of this study were to 1) perform comprehensive sequencing of germline and tumor tissues (exome and RNA seq), 2) identify genomic alterations and perturbed pathways associated with response/resistance to standard chemotherapy, and 3) develop patient-derived xenograft (PDX) for testing of therapeutic regimens chosen on the basis of alterations identified by genetic sequencing.

Link

dbGaP study = phs001050

Stichworte

Versionen (1)
  1. 23.06.23 23.06.23 - Simon Heim
Rechteinhaber

Matthew Goetz, MD, Mayo Clinic, Rochester, MN, USA

Hochgeladen am

23. Juni 2023

DOI

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Lizenz

Creative Commons BY 4.0
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    dbGaP phs001050 Breast Cancer Genome Guided Therapy Study (BEAUTY)

    Englisch

    Eligibility Criteria

    5 Formulare  
    Inclusion and exclusion criteria
    Beschreibung

    Inclusion and exclusion criteria

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    **Inclusion Criteria*:* 1) Age ≥18 years. 2) Histological confirmation of invasive breast cancer. 3) Confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or MRI) in the ipsilateral breast. Note: Benign breast disease, LCIS or DCIS in the contralateral breast is allowed. Contralateral invasive breast cancer is allowed if disease is of clinically lower stage and the higher stage lesion will be the study lesion for all biopsies and tissue samples. 4) Provide informed written consent. 5) Willing to return to Mayo Clinic in Rochester, MN, Mayo Clinic in Arizona, or Mayo Clinic in Florida for imaging correlative, surgery, and follow-up. 6) Willing to provide blood samples for correlative research purposes. 7) Willing to provide tissue samples for correlative research purposes. 8) ECOG Performance Status ≤ 2. **Exclusion Criteria*:* 1) Disease in axilla only 2) Receiving any investigational agent which would be considered as a treatment for the primary neoplasm. 3) Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving any other treatment for their cancer. 4) Patients who are not planning to receive neoadjuvant chemotherapy. 5) Biopsy proven Stage IV disease. 6) Patients who are pregnant or nursing.
    Beschreibung

    **Inclusion Criteria*:* 1) Age ≥18 years. 2) Histological confirmation of invasive breast cancer. 3) Confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or MRI) in the ipsilateral breast. Note: Benign breast disease, LCIS or DCIS in the contralateral breast is allowed. Contralateral invasive breast cancer is allowed if disease is of clinically lower stage and the higher stage lesion will be the study lesion for all biopsies and tissue samples. 4) Provide informed written consent. 5) Willing to return to Mayo Clinic in Rochester, MN, Mayo Clinic in Arizona, or Mayo Clinic in Florida for imaging correlative, surgery, and follow-up. 6) Willing to provide blood samples for correlative research purposes. 7) Willing to provide tissue samples for correlative research purposes. 8) ECOG Performance Status ≤ 2. **Exclusion Criteria*:* 1) Disease in axilla only 2) Receiving any investigational agent which would be considered as a treatment for the primary neoplasm. 3) Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving any other treatment for their cancer. 4) Patients who are not planning to receive neoadjuvant chemotherapy. 5) Biopsy proven Stage IV disease. 6) Patients who are pregnant or nursing.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0001779
    UMLS CUI [2,1]
    C1512693
    UMLS CUI [2,2]
    C0205462
    UMLS CUI [2,3]
    C0521091
    UMLS CUI [2,4]
    C0853879
    UMLS CUI [3,1]
    C1512693
    UMLS CUI [3,2]
    C0678222
    UMLS CUI [3,3]
    C0449453
    UMLS CUI [3,4]
    C0679228
    UMLS CUI [4,1]
    C1512693
    UMLS CUI [4,2]
    C0441989
    UMLS CUI [4,3]
    C0279563
    UMLS CUI [4,4]
    C5231168
    UMLS CUI [5,1]
    C1512693
    UMLS CUI [5,2]
    C0441988
    UMLS CUI [5,3]
    C0853879
    UMLS CUI [5,4]
    C0205563
    UMLS CUI [5,5]
    C0221198
    UMLS CUI [5,6]
    C0947630
    UMLS CUI [5,7]
    C0005558
    UMLS CUI [5,8]
    C0475358
    UMLS CUI [6,1]
    C1512693
    UMLS CUI [6,2]
    C0021430
    UMLS CUI [7,1]
    C1512693
    UMLS CUI [7,2]
    C0600109
    UMLS CUI [7,3]
    C2347790
    UMLS CUI [7,4]
    C0011923
    UMLS CUI [7,5]
    C0543467
    UMLS CUI [7,6]
    C1522577
    UMLS CUI [8,1]
    C1512693
    UMLS CUI [8,2]
    C0600109
    UMLS CUI [8,3]
    C1292533
    UMLS CUI [8,4]
    C0178913
    UMLS CUI [8,5]
    C0242481
    UMLS CUI [9,1]
    C1512693
    UMLS CUI [9,2]
    C1520224
    UMLS CUI [10,1]
    C0680251
    UMLS CUI [10,2]
    C1515974
    UMLS CUI [10,3]
    C0004454
    UMLS CUI [10,4]
    C1548966
    UMLS CUI [11,1]
    C0680251
    UMLS CUI [11,2]
    C0949266
    UMLS CUI [12,1]
    C0680251
    UMLS CUI [12,2]
    C0205394
    UMLS CUI [12,3]
    C0205177
    UMLS CUI [12,4]
    C0006826
    UMLS CUI [12,5]
    C1948053
    UMLS CUI [12,6]
    C0332300
    UMLS CUI [12,7]
    C3846158
    UMLS CUI [12,8]
    C0851140
    UMLS CUI [13,1]
    C0680251
    UMLS CUI [13,2]
    C1298908
    UMLS CUI [13,3]
    C0162425
    UMLS CUI [13,4]
    C5392214
    UMLS CUI [14,1]
    C0680251
    UMLS CUI [14,2]
    C0441772
    UMLS CUI [14,3]
    C0005558
    UMLS CUI [15,1]
    C0680251
    UMLS CUI [15,2]
    C5443927
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Criteria

    5 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Inclusion and exclusion criteria
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    **Inclusion Criteria*:* 1) Age ≥18 years. 2) Histological confirmation of invasive breast cancer. 3) Confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or MRI) in the ipsilateral breast. Note: Benign breast disease, LCIS or DCIS in the contralateral breast is allowed. Contralateral invasive breast cancer is allowed if disease is of clinically lower stage and the higher stage lesion will be the study lesion for all biopsies and tissue samples. 4) Provide informed written consent. 5) Willing to return to Mayo Clinic in Rochester, MN, Mayo Clinic in Arizona, or Mayo Clinic in Florida for imaging correlative, surgery, and follow-up. 6) Willing to provide blood samples for correlative research purposes. 7) Willing to provide tissue samples for correlative research purposes. 8) ECOG Performance Status ≤ 2. **Exclusion Criteria*:* 1) Disease in axilla only 2) Receiving any investigational agent which would be considered as a treatment for the primary neoplasm. 3) Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving any other treatment for their cancer. 4) Patients who are not planning to receive neoadjuvant chemotherapy. 5) Biopsy proven Stage IV disease. 6) Patients who are pregnant or nursing.
    Item
    **Inclusion Criteria*:* 1) Age ≥18 years. 2) Histological confirmation of invasive breast cancer. 3) Confirmation of breast cancer lesion ≥ 1.5 cm in size by any clinical (physical examination measurement) or radiographic criteria (mammogram, ultrasound or MRI) in the ipsilateral breast. Note: Benign breast disease, LCIS or DCIS in the contralateral breast is allowed. Contralateral invasive breast cancer is allowed if disease is of clinically lower stage and the higher stage lesion will be the study lesion for all biopsies and tissue samples. 4) Provide informed written consent. 5) Willing to return to Mayo Clinic in Rochester, MN, Mayo Clinic in Arizona, or Mayo Clinic in Florida for imaging correlative, surgery, and follow-up. 6) Willing to provide blood samples for correlative research purposes. 7) Willing to provide tissue samples for correlative research purposes. 8) ECOG Performance Status ≤ 2. **Exclusion Criteria*:* 1) Disease in axilla only 2) Receiving any investigational agent which would be considered as a treatment for the primary neoplasm. 3) Other active malignancy ≤ 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving any other treatment for their cancer. 4) Patients who are not planning to receive neoadjuvant chemotherapy. 5) Biopsy proven Stage IV disease. 6) Patients who are pregnant or nursing.
    boolean
    C1512693 (UMLS CUI [1,1])
    C0001779 (UMLS CUI [1,2])
    C1512693 (UMLS CUI [2,1])
    C0205462 (UMLS CUI [2,2])
    C0521091 (UMLS CUI [2,3])
    C0853879 (UMLS CUI [2,4])
    C1512693 (UMLS CUI [3,1])
    C0678222 (UMLS CUI [3,2])
    C0449453 (UMLS CUI [3,3])
    C0679228 (UMLS CUI [3,4])
    C1512693 (UMLS CUI [4,1])
    C0441989 (UMLS CUI [4,2])
    C0279563 (UMLS CUI [4,3])
    C5231168 (UMLS CUI [4,4])
    C1512693 (UMLS CUI [5,1])
    C0441988 (UMLS CUI [5,2])
    C0853879 (UMLS CUI [5,3])
    C0205563 (UMLS CUI [5,4])
    C0221198 (UMLS CUI [5,5])
    C0947630 (UMLS CUI [5,6])
    C0005558 (UMLS CUI [5,7])
    C0475358 (UMLS CUI [5,8])
    C1512693 (UMLS CUI [6,1])
    C0021430 (UMLS CUI [6,2])
    C1512693 (UMLS CUI [7,1])
    C0600109 (UMLS CUI [7,2])
    C2347790 (UMLS CUI [7,3])
    C0011923 (UMLS CUI [7,4])
    C0543467 (UMLS CUI [7,5])
    C1522577 (UMLS CUI [7,6])
    C1512693 (UMLS CUI [8,1])
    C0600109 (UMLS CUI [8,2])
    C1292533 (UMLS CUI [8,3])
    C0178913 (UMLS CUI [8,4])
    C0242481 (UMLS CUI [8,5])
    C1512693 (UMLS CUI [9,1])
    C1520224 (UMLS CUI [9,2])
    C0680251 (UMLS CUI [10,1])
    C1515974 (UMLS CUI [10,2])
    C0004454 (UMLS CUI [10,3])
    C1548966 (UMLS CUI [10,4])
    C0680251 (UMLS CUI [11,1])
    C0949266 (UMLS CUI [11,2])
    C0680251 (UMLS CUI [12,1])
    C0205394 (UMLS CUI [12,2])
    C0205177 (UMLS CUI [12,3])
    C0006826 (UMLS CUI [12,4])
    C1948053 (UMLS CUI [12,5])
    C0332300 (UMLS CUI [12,6])
    C3846158 (UMLS CUI [12,7])
    C0851140 (UMLS CUI [12,8])
    C0680251 (UMLS CUI [13,1])
    C1298908 (UMLS CUI [13,2])
    C0162425 (UMLS CUI [13,3])
    C5392214 (UMLS CUI [13,4])
    C0680251 (UMLS CUI [14,1])
    C0441772 (UMLS CUI [14,2])
    C0005558 (UMLS CUI [14,3])
    C0680251 (UMLS CUI [15,1])
    C5443927 (UMLS CUI [15,2])
    Zum Seitenanfang zurückkehren 

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