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Prospective study of outcomes in Sporadic versus hereditary breast cancer (POSH): study protocol

Prospective study of outcomes in Sporadic versus hereditary breast cancer (POSH): study protocol
Prospective study of outcomes in Sporadic versus hereditary breast cancer (POSH): study protocol
Background: young women presenting with breast cancer are more likely to have a genetic predisposition to the disease than breast cancer patients in general. A genetic predisposition is known to increase the risk of new primary breast (and other) cancers. It is unclear from the literature whether genetic status should be taken into consideration when planning adjuvant treatment in a young woman presenting with a first primary breast cancer. The primary aim of the POSH study is to establish whether genetic status influences the prognosis of primary breast cancer independently of known prognostic factors.

Methods/design: the study is a prospective cohort study recruiting 3,000 women aged 40 years or younger at breast cancer diagnosis; the recruiting period covers 1st June 2001 to 31st December 2007. Written informed consent is obtained at study entry. Family history and known epidemiological risk data are collected by questionnaire. Clinical information about diagnosis, treatment and clinical course is collected and blood is stored. Follow up data are collected annually after the first year. An additional recruitment category includes women aged 41 to 50 years who are found to be BRCA1 or BRCA2 gene carriers and were diagnosed with their first breast cancer during the study recruiting period.

Discussion: power estimates were based on 10% of the cohort carrying a BRCA1 gene mutation. Preliminary BRCA1 and BRCA2 mutation analysis in a pilot set of study participants confirms we should have 97% power to detect a difference of 10% in event rates between gene carriers and sporadic young onset cases. Most of the recruited patients (>80%) receive an anthracycline containing adjuvant chemotherapy regimen making planned analyses more straightforward
aged, mutation, cohort, surgery, disease, cancer, combined modality therapy, patients, treatment outcome, middle aged, hospitals, genes, prospective studies, analysis, literature, follow-up studies, cohort studies, research design, brca2, breast neoplasms, research, brca1, humans, england, risk factors, risk, breast cancer, diagnosis, blood, questionnaires, informed consent, genetics, treatment, adult, comparative study, research support, epidemiology, biological specimen banks, family, history, neoplastic syndromes, prognosis, female, hereditary, drug therapy
1471-2407
[6pp]
Eccles, Diana
5b59bc73-11c9-4cf0-a9d5-7a8e523eee23
Gerty, Sue
b2013815-27c9-4a7d-ad42-071f60a8000f
Simmonds, Peter
27d4c068-e352-4cbf-9899-771893788ade
Hammond, Victoria
12061d78-c9da-4c15-ad78-a3e6e6a4e672
Ennis, Sarah
7b57f188-9d91-4beb-b217-09856146f1e9
Altman, Douglas G.
f0d739a4-dc94-44d1-a497-603a3ed7d7e6
Eccles, Diana
5b59bc73-11c9-4cf0-a9d5-7a8e523eee23
Gerty, Sue
b2013815-27c9-4a7d-ad42-071f60a8000f
Simmonds, Peter
27d4c068-e352-4cbf-9899-771893788ade
Hammond, Victoria
12061d78-c9da-4c15-ad78-a3e6e6a4e672
Ennis, Sarah
7b57f188-9d91-4beb-b217-09856146f1e9
Altman, Douglas G.
f0d739a4-dc94-44d1-a497-603a3ed7d7e6

Eccles, Diana, Gerty, Sue, Simmonds, Peter, Hammond, Victoria, Ennis, Sarah and Altman, Douglas G. (2007) Prospective study of outcomes in Sporadic versus hereditary breast cancer (POSH): study protocol. BMC cancer, 7, [6pp]. (doi:10.1186/1471-2407-7-160).

Record type: Article

Abstract

Background: young women presenting with breast cancer are more likely to have a genetic predisposition to the disease than breast cancer patients in general. A genetic predisposition is known to increase the risk of new primary breast (and other) cancers. It is unclear from the literature whether genetic status should be taken into consideration when planning adjuvant treatment in a young woman presenting with a first primary breast cancer. The primary aim of the POSH study is to establish whether genetic status influences the prognosis of primary breast cancer independently of known prognostic factors.

Methods/design: the study is a prospective cohort study recruiting 3,000 women aged 40 years or younger at breast cancer diagnosis; the recruiting period covers 1st June 2001 to 31st December 2007. Written informed consent is obtained at study entry. Family history and known epidemiological risk data are collected by questionnaire. Clinical information about diagnosis, treatment and clinical course is collected and blood is stored. Follow up data are collected annually after the first year. An additional recruitment category includes women aged 41 to 50 years who are found to be BRCA1 or BRCA2 gene carriers and were diagnosed with their first breast cancer during the study recruiting period.

Discussion: power estimates were based on 10% of the cohort carrying a BRCA1 gene mutation. Preliminary BRCA1 and BRCA2 mutation analysis in a pilot set of study participants confirms we should have 97% power to detect a difference of 10% in event rates between gene carriers and sporadic young onset cases. Most of the recruited patients (>80%) receive an anthracycline containing adjuvant chemotherapy regimen making planned analyses more straightforward

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More information

Published date: 15 August 2007
Keywords: aged, mutation, cohort, surgery, disease, cancer, combined modality therapy, patients, treatment outcome, middle aged, hospitals, genes, prospective studies, analysis, literature, follow-up studies, cohort studies, research design, brca2, breast neoplasms, research, brca1, humans, england, risk factors, risk, breast cancer, diagnosis, blood, questionnaires, informed consent, genetics, treatment, adult, comparative study, research support, epidemiology, biological specimen banks, family, history, neoplastic syndromes, prognosis, female, hereditary, drug therapy
Organisations: Faculty of Medicine, Cancer Sciences, Clinical Trials Unit

Identifiers

Local EPrints ID: 59690
URI: http://eprints.soton.ac.uk/id/eprint/59690
ISSN: 1471-2407
PURE UUID: 8f791de5-3f66-4e8c-8a0c-8a2f02991165
ORCID for Diana Eccles: ORCID iD orcid.org/0000-0002-9935-3169
ORCID for Sarah Ennis: ORCID iD orcid.org/0000-0003-2648-0869

Catalogue record

Date deposited: 03 Sep 2008
Last modified: 19 Feb 2021 02:32

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