ID

45808

Descrição

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

Palavras-chave

Versões (1)
  1. 23/06/2023 23/06/2023 - Simon Heim
Titular dos direitos

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

Transferido a

23 de junho de 2023

DOI

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Licença

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

Inglês

Eligibility Criteria

5 Formulários  
Inclusion and exclusion criteria
Descrição

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.
Descrição

**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.

Tipo de dados

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
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Similar models

Eligibility Criteria

5 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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