ID

45406

Beschrijving

Principal Investigator: Susan E. Clare, MD, PhD, Indiana University School of Medicine, Indianapolis, IN, USA MeSH: Menstrual Cycle,Breast https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000644 The Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center [www.komentissuebank.iu.edu] (KTB) was established expressly for the prospective collection of normal, healthy breast tissue from volunteer donors. Blood is also obtained from donors at the time of donation and is processed for serum, plasma and peripheral blood leukocyte DNA. Specimens are annotated and data includes age, race, ethnicity, personal health history, family cancer history, medication usage at the time of donation, and breast cancer risk factors. Premenopausal donors to the KTB were identified by a query of the Bank's database. Hematoxylin and eosin stained sections of the formalin-fixed paraffin-embedded tissue of the identified donors were reviewed and tissue was graded on the basis of the abundance of epithelium within the section. Only tissue containing abundant epithelium was considered for this study. Based on dates, the specimens of nine women in the follicular phase of the menstrual cycle and five in the luteal phase were chosen. Six donors using hormonal contraception at the time of donation were also included. Whole blood obtained from 19 of the 20 donors at the time of tissue donation was available and it was processed for serum. Estradiol, estriol, luteinizing hormone and progesterone concentrations were determined by the Indiana University Health Pathology Laboratory using a Beckman Unicel DxI 800 Immunoassay System. The phase of the menstrual cycle was verified by serum progesterone concentration. The epithelium of these 20 specimens was microdissected from multiple 8 micron frozen tissue sections. Total RNA extracted from the tissue was subsequently depleted of rRNA via locked nucleic acid probes. This enabled profiling of both poly-A and non-poly-A RNA species. Barcoded cDNA libraries from the 20 normal breast epithelia were prepared and sequenced on an Applied Biosystems (AB) SOLiD3 or SOLiD 4 platform. RNA-seq reads for each sample were then mapped to the human genome (hg19) using the LifeScope software version 2.5.1 (Life Technologies, Foster City, CA) and BAM (Binary Alignment/Map) files generated. Read counts for each gene were derived from the output BAM files using the RefSeq database (UCSC Genome Brower) as the gene model.

Link

dbGaP study = phs000644

Trefwoorden

  1. 19-11-22 19-11-22 - Simon Heim
Houder van rechten

Susan E. Clare, MD, PhD, Indiana University School of Medicine, Indianapolis, IN, USA

Geüploaded op

19 november 2022

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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dbGaP phs000644 The Effect of the Menstrual Cycle on the Normal Human Breast

Eligibility Criteria

Inclusion and exclusion criteria
Beschrijving

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
For donation to the KTB:
Beschrijving

For donation to the KTB:

Datatype

boolean

Alias
UMLS CUI [1,1]
C3854058
UMLS CUI [1,2]
C0040278
*Inclusion Criteria:*
Beschrijving

*Inclusion Criteria:*

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
Women ages ≥ 18 years without known active breast cancer.
Beschrijving

Women ages ≥ 18 years without known active breast cancer.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0043210
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0205309
UMLS CUI [1,5]
C0678222
Women ages ≥ 18 years with Stage 0-IV breast cancer. In these women, tissue collection will be limited to blood, salvia, etc. The cancer patient's malignant tissue (breast or metastatic site) will not be included in this bank.
Beschrijving

Women ages ≥ 18 years with Stage 0-IV breast cancer. In these women, tissue collection will be limited to blood, salvia, etc. The cancer patient's malignant tissue (breast or metastatic site) will not be included in this bank.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0678222
UMLS CUI [1,4]
C0449705
UMLS CUI [1,5]
C0200345
UMLS CUI [1,6]
C0449295
UMLS CUI [1,7]
C0678222
UMLS CUI [2,1]
C1516213
UMLS CUI [2,2]
C2713035
UMLS CUI [2,3]
C0027651
UMLS CUI [2,4]
C2828389
UMLS CUI [2,5]
C0040278
Ability to understand and the willingness to sign an informed consent document.
Beschrijving

Ability to understand and the willingness to sign an informed consent document.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
*Exclusion Criteria:*
Beschrijving

*Exclusion Criteria:*

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Beschrijving

Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0278061
UMLS CUI [1,3]
C0004936
UMLS CUI [1,4]
C0683610
UMLS CUI [1,5]
C0021430
For biopsy of breast tissue only: History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).
Beschrijving

For biopsy of breast tissue only: History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).

Datatype

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C2106654
UMLS CUI [1,3]
C0002934
Anticoagulation: For the purpose of invasive breast biopsies, women may not be receiving therapeutic anticoagulants. For blood draws, anticoagulants will be permitted.
Beschrijving

Anticoagulation: For the purpose of invasive breast biopsies, women may not be receiving therapeutic anticoagulants. For blood draws, anticoagulants will be permitted.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C3242385
UMLS CUI [1,3]
C0003280
Any other condition, which in the opinion of the physician performing the biopsy procedure would make participation in this protocol unreasonably hazardous for the subject.
Beschrijving

Any other condition, which in the opinion of the physician performing the biopsy procedure would make participation in this protocol unreasonably hazardous for the subject.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0600219
UMLS CUI [1,4]
C0031831
For the purpose of invasive breast biopsies, women may not have had breast implants or breast reduction surgery.
Beschrijving

For the purpose of invasive breast biopsies, women may not have had breast implants or breast reduction surgery.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0917968
UMLS CUI [1,4]
C0332122
UMLS CUI [1,5]
C0741761
*For inclusion in this study:*
Beschrijving

*For inclusion in this study:*

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
The hematoxylin and eosin section had to demonstrate sufficient epithelium so that it would be reasonable to predict that a sufficient amount of RNA would be isolated for sequencing.
Beschrijving

The hematoxylin and eosin section had to demonstrate sufficient epithelium so that it would be reasonable to predict that a sufficient amount of RNA would be isolated for sequencing.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0523207
UMLS CUI [1,2]
C0014609
UMLS CUI [1,3]
C0681842
UMLS CUI [1,4]
C0205410
UMLS CUI [1,5]
C1265611
UMLS CUI [1,6]
C0035668
UMLS CUI [1,7]
C0204727
UMLS CUI [1,8]
C1561491

Similar models

Eligibility Criteria

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
For donation to the KTB:
Item
For donation to the KTB:
boolean
C3854058 (UMLS CUI [1,1])
C0040278 (UMLS CUI [1,2])
*Inclusion Criteria:*
Item
*Inclusion Criteria:*
boolean
C1512693 (UMLS CUI [1,1])
Women ages ≥ 18 years without known active breast cancer.
Item
Women ages ≥ 18 years without known active breast cancer.
boolean
C0001779 (UMLS CUI [1,1])
C0043210 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0205309 (UMLS CUI [1,4])
C0678222 (UMLS CUI [1,5])
Women ages ≥ 18 years with Stage 0-IV breast cancer. In these women, tissue collection will be limited to blood, salvia, etc. The cancer patient's malignant tissue (breast or metastatic site) will not be included in this bank.
Item
Women ages ≥ 18 years with Stage 0-IV breast cancer. In these women, tissue collection will be limited to blood, salvia, etc. The cancer patient's malignant tissue (breast or metastatic site) will not be included in this bank.
boolean
C0043210 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0449705 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,5])
C0449295 (UMLS CUI [1,6])
C0678222 (UMLS CUI [1,7])
C1516213 (UMLS CUI [2,1])
C2713035 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C2828389 (UMLS CUI [2,4])
C0040278 (UMLS CUI [2,5])
Ability to understand and the willingness to sign an informed consent document.
Item
Ability to understand and the willingness to sign an informed consent document.
boolean
C0021430 (UMLS CUI [1,1])
*Exclusion Criteria:*
Item
*Exclusion Criteria:*
boolean
C0680251 (UMLS CUI [1,1])
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Item
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
boolean
C0497327 (UMLS CUI [1,1])
C0278061 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0683610 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,5])
For biopsy of breast tissue only: History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).
Item
For biopsy of breast tissue only: History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).
boolean
C0405352 (UMLS CUI [1,1])
C2106654 (UMLS CUI [1,2])
C0002934 (UMLS CUI [1,3])
Anticoagulation: For the purpose of invasive breast biopsies, women may not be receiving therapeutic anticoagulants. For blood draws, anticoagulants will be permitted.
Item
Anticoagulation: For the purpose of invasive breast biopsies, women may not be receiving therapeutic anticoagulants. For blood draws, anticoagulants will be permitted.
boolean
C0405352 (UMLS CUI [1,1])
C3242385 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
Any other condition, which in the opinion of the physician performing the biopsy procedure would make participation in this protocol unreasonably hazardous for the subject.
Item
Any other condition, which in the opinion of the physician performing the biopsy procedure would make participation in this protocol unreasonably hazardous for the subject.
boolean
C0405352 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0600219 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
For the purpose of invasive breast biopsies, women may not have had breast implants or breast reduction surgery.
Item
For the purpose of invasive breast biopsies, women may not have had breast implants or breast reduction surgery.
boolean
C0405352 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0917968 (UMLS CUI [1,3])
C0332122 (UMLS CUI [1,4])
C0741761 (UMLS CUI [1,5])
*For inclusion in this study:*
Item
*For inclusion in this study:*
boolean
C1512693 (UMLS CUI [1,1])
The hematoxylin and eosin section had to demonstrate sufficient epithelium so that it would be reasonable to predict that a sufficient amount of RNA would be isolated for sequencing.
Item
The hematoxylin and eosin section had to demonstrate sufficient epithelium so that it would be reasonable to predict that a sufficient amount of RNA would be isolated for sequencing.
boolean
C0523207 (UMLS CUI [1,1])
C0014609 (UMLS CUI [1,2])
C0681842 (UMLS CUI [1,3])
C0205410 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,5])
C0035668 (UMLS CUI [1,6])
C0204727 (UMLS CUI [1,7])
C1561491 (UMLS CUI [1,8])

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