ID

45554

Beschrijving

Principal Investigator: Clarice Weinberg, PhD, National Institutes of Health, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000678 To study environmental and genetic causes of young onset breast cancer, we recruited women who had been young when recently diagnosed (under age 50 and within 4 years of enrollment), and had been identified as potentially eligible by a sister who was already participating in the ongoing Sister Study. The unaffected sister had already provided consent, questionnaire-based information and DNA (blood-based) when she enrolled in the Sister Study. Her case sister then provided comparable questionnaire-based information and DNA via a mail-back saliva collection kit. To enable family-based analyses, parents were also asked to (only) provide consent and a saliva sample. Because the cases were young-onset, most parents were alive, but unavailability of the parents was not a basis for exclusion. The study was funded in part by Susan G. Komen for the Cure.

Link

dbGaP study = phs000678

Trefwoorden

Versies (1)
  1. 09-01-23 09-01-23 - Simon Heim
Houder van rechten

Clarice Weinberg, PhD, National Institutes of Health, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA

Geüploaded op

9 januari 2023

DOI

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Licentie

Creative Commons BY 4.0
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dbGaP phs000678 A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer

Engels

Eligibility Criteria

6 Formulieren  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, subject source ID, and affection status of participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    3. Subject ID, family ID, father ID, mother ID, sex, and twin ID of participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    4. Subject ID, sample ID, sample source, sample source ID, and sample use variable obtained from participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    5. Subject ID, case or control status of participant, age at first pregnancy, age at menarche, medical history of breast cancer of mother or sister, age at breast cancer onset, index of age, birth order among participating siblings, race/ethnicity, and menopausal status of participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    6. Sample ID, body site, analyte type, tumor status of sample, histological type, and genotyping center associated with participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
Inclusion and exclusion criteria
Beschrijving

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Controls were women whose sister had been diagnosed with breast cancer. They had to be between 35 and 75 years old, be living in the US or Puerto Rico, and be fluent in either English or Spanish. They agreed to be followed over time, to participate in two lengthy interviews by phone and submit to a blood draw, urine and house dust collection, and measurement of blood pressure and weight. They provided informed consent. Their information included their sister's age at diagnosis and how recently it had occurred. The sister did not have to be living.
Beschrijving

Controls were women whose sister had been diagnosed with breast cancer. They had to be between 35 and 75 years old, be living in the US or Puerto Rico, and be fluent in either English or Spanish. They agreed to be followed over time, to participate in two lengthy interviews by phone and submit to a blood draw, urine and house dust collection, and measurement of blood pressure and weight. They provided informed consent. Their information included their sister's age at diagnosis and how recently it had occurred. The sister did not have to be living.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0337514
UMLS CUI [1,3]
C0011900
UMLS CUI [1,4]
C0006142
UMLS CUI [1,5]
C0001779
UMLS CUI [1,6]
C2316216
UMLS CUI [1,7]
C0041703
UMLS CUI [1,8]
C0034044
UMLS CUI [1,9]
C0376245
UMLS CUI [1,10]
C0037750
UMLS CUI [1,11]
C1511481
UMLS CUI [1,12]
C0589121
UMLS CUI [1,13]
C0021822
UMLS CUI [1,14]
C5401001
UMLS CUI [1,15]
C0200354
UMLS CUI [1,16]
C0524581
UMLS CUI [1,17]
C0005823
UMLS CUI [1,18]
C0005910
UMLS CUI [1,19]
C1828181
UMLS CUI [1,20]
C4743985
UMLS CUI [1,21]
C2745955
Cases were women whose full sister was fully enrolled in the Sister Study. They had to be able to answer questions in English and they had to have been diagnosed before age 50 and within 4 years of enrollment. They agreed to be followed over time, to participate in three interviews by phone and provide saliva for DNA extraction via a mail-back kit (Oragene) and they provided informed consent. They were asked to send a letter from us to their parents, inviting them to provide saliva samples. Parents provided informed consent for genotyping. The consent forms all made clear that genotype results would not be returned to participants.
Beschrijving

Cases were women whose full sister was fully enrolled in the Sister Study. They had to be able to answer questions in English and they had to have been diagnosed before age 50 and within 4 years of enrollment. They agreed to be followed over time, to participate in three interviews by phone and provide saliva for DNA extraction via a mail-back kit (Oragene) and they provided informed consent. They were asked to send a letter from us to their parents, inviting them to provide saliva samples. Parents provided informed consent for genotyping. The consent forms all made clear that genotype results would not be returned to participants.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C5418626
UMLS CUI [1,3]
C0337514
UMLS CUI [1,4]
C0508431
UMLS CUI [1,5]
C0376245
UMLS CUI [1,6]
C0011900
UMLS CUI [1,7]
C0001779
UMLS CUI [1,8]
C0021430
UMLS CUI [1,9]
C0589121
UMLS CUI [1,10]
C0021822
UMLS CUI [1,11]
C0438730
UMLS CUI [1,12]
C3839098
UMLS CUI [1,13]
C0024492
UMLS CUI [1,14]
C0030551
UMLS CUI [1,15]
C4757946
UMLS CUI [1,16]
C1285573
When both parents were available, the control sister was not genotyped, as non-transmitted parental alleles can fill that role.
Beschrijving

When both parents were available, the control sister was not genotyped, as non-transmitted parental alleles can fill that role.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C1285573
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Similar models

Eligibility Criteria

6 Formulieren
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, subject source ID, and affection status of participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    3. Subject ID, family ID, father ID, mother ID, sex, and twin ID of participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    4. Subject ID, sample ID, sample source, sample source ID, and sample use variable obtained from participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    5. Subject ID, case or control status of participant, age at first pregnancy, age at menarche, medical history of breast cancer of mother or sister, age at breast cancer onset, index of age, birth order among participating siblings, race/ethnicity, and menopausal status of participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
    6. Sample ID, body site, analyte type, tumor status of sample, histological type, and genotyping center associated with participants with or without breast cancer and involved in the "The Two Sister Study: A Family-Based Study of Genes and Environment in Young-Onset Breast Cancer" project.
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])
Controls were women whose sister had been diagnosed with breast cancer. They had to be between 35 and 75 years old, be living in the US or Puerto Rico, and be fluent in either English or Spanish. They agreed to be followed over time, to participate in two lengthy interviews by phone and submit to a blood draw, urine and house dust collection, and measurement of blood pressure and weight. They provided informed consent. Their information included their sister's age at diagnosis and how recently it had occurred. The sister did not have to be living.
Item
Controls were women whose sister had been diagnosed with breast cancer. They had to be between 35 and 75 years old, be living in the US or Puerto Rico, and be fluent in either English or Spanish. They agreed to be followed over time, to participate in two lengthy interviews by phone and submit to a blood draw, urine and house dust collection, and measurement of blood pressure and weight. They provided informed consent. Their information included their sister's age at diagnosis and how recently it had occurred. The sister did not have to be living.
boolean
C0009932 (UMLS CUI [1,1])
C0337514 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0006142 (UMLS CUI [1,4])
C0001779 (UMLS CUI [1,5])
C2316216 (UMLS CUI [1,6])
C0041703 (UMLS CUI [1,7])
C0034044 (UMLS CUI [1,8])
C0376245 (UMLS CUI [1,9])
C0037750 (UMLS CUI [1,10])
C1511481 (UMLS CUI [1,11])
C0589121 (UMLS CUI [1,12])
C0021822 (UMLS CUI [1,13])
C5401001 (UMLS CUI [1,14])
C0200354 (UMLS CUI [1,15])
C0524581 (UMLS CUI [1,16])
C0005823 (UMLS CUI [1,17])
C0005910 (UMLS CUI [1,18])
C1828181 (UMLS CUI [1,19])
C4743985 (UMLS CUI [1,20])
C2745955 (UMLS CUI [1,21])
Cases were women whose full sister was fully enrolled in the Sister Study. They had to be able to answer questions in English and they had to have been diagnosed before age 50 and within 4 years of enrollment. They agreed to be followed over time, to participate in three interviews by phone and provide saliva for DNA extraction via a mail-back kit (Oragene) and they provided informed consent. They were asked to send a letter from us to their parents, inviting them to provide saliva samples. Parents provided informed consent for genotyping. The consent forms all made clear that genotype results would not be returned to participants.
Item
Cases were women whose full sister was fully enrolled in the Sister Study. They had to be able to answer questions in English and they had to have been diagnosed before age 50 and within 4 years of enrollment. They agreed to be followed over time, to participate in three interviews by phone and provide saliva for DNA extraction via a mail-back kit (Oragene) and they provided informed consent. They were asked to send a letter from us to their parents, inviting them to provide saliva samples. Parents provided informed consent for genotyping. The consent forms all made clear that genotype results would not be returned to participants.
boolean
C1706256 (UMLS CUI [1,1])
C5418626 (UMLS CUI [1,2])
C0337514 (UMLS CUI [1,3])
C0508431 (UMLS CUI [1,4])
C0376245 (UMLS CUI [1,5])
C0011900 (UMLS CUI [1,6])
C0001779 (UMLS CUI [1,7])
C0021430 (UMLS CUI [1,8])
C0589121 (UMLS CUI [1,9])
C0021822 (UMLS CUI [1,10])
C0438730 (UMLS CUI [1,11])
C3839098 (UMLS CUI [1,12])
C0024492 (UMLS CUI [1,13])
C0030551 (UMLS CUI [1,14])
C4757946 (UMLS CUI [1,15])
C1285573 (UMLS CUI [1,16])
When both parents were available, the control sister was not genotyped, as non-transmitted parental alleles can fill that role.
Item
When both parents were available, the control sister was not genotyped, as non-transmitted parental alleles can fill that role.
boolean
C0470187 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C1285573 (UMLS CUI [1,3])
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