- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01320488
Breast Cancer in Young Women: Is it Different? (YoungWomen)
12. maj 2016 opdateret af: National Guard Health Affairs
Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third of cancer diagnosed in Saudi women.
Breast cancer in Saudi women is more frequently observed at young age.
The data on this observation is either lacking or scares.
Furthermore, the pathological and molecular features of breast cancer in young women are not clear.
The study will provide important information to the national health care planner about this disease in young women including shedding light on possible genetic risk factors
Studieoversigt
Status
Suspenderet
Betingelser
Detaljeret beskrivelse
The study is a prospective longitudinal cohort study of young women with breast cancer.
Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area.
It is anticipated at least 400 of these women will agree to participate in the study.
The comparable control group of older patients with breast cancer will be used for study comparison.
Patient surveys, medical record review, and blood and tissue collection will be utilized.
Women will be surveyed every 6 months after diagnosis.
The study will investigate short and long-term disease and treatment issues, and psychosocial concerns.
We will also collect tumor and blood samples to characterize the pathological and molecular aspects of tumors, and establish tumor bank for future studies.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
600
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Riyadh, Saudi Arabien, 11426
- King Abdul Aziz Medical City for National Guard Health Affairs
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The proposed project is a prospective longitudinal cohort study of young women with breast cancer.
Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area.
It is anticipated that at least 400 of these women (from study and control group) will agree to participate in the study.
Beskrivelse
Inclusion Criteria:
- Female
- Diagnosis of breast cancer
- Age 40 or younger at diagnosis for study group and older women for control group
- Informed consent obtained from patient
Exclusion Criteria:
- Absence of informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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experience of breast cancer in young women
Tidsramme: 10 years
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To identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer in King Abdulaziz Medical City and other collaborating hospitals to assess a broad range of variables at baseline and over the course.
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10 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Omalkahir Abulkhair, MD, King Abdul Aziz Medical City for National Guard
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Forventet)
1. august 2016
Studieafslutning (Forventet)
1. august 2016
Datoer for studieregistrering
Først indsendt
19. marts 2011
Først indsendt, der opfyldte QC-kriterier
19. marts 2011
Først opslået (Skøn)
22. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC08/117
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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