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Outcome of Pregnancy and Breast Cancer (Pregnancy)

12. maj 2016 opdateret af: National Guard Health Affairs

Outcome of Pregnancy Associated Breast Cancer (PABC) in Saudi Arabia ; Prospective Cohort Study.

Investigators are interested to explore the clinical and pathological characteristics of breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during pregnancy, median gestational age at diagnosis, the level of the tumor differentiation patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan to collect prospective quality research databases that could provide further important information concerning this condition and serve in both short- and long-term sequelae in mother and fetus.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Breast cancer is classified as pregnancy-associated if it is diagnosed during pregnancy or within one year of delivery . About 3% of all breast cancers are diagnosed during pregnancy . The average age at diagnosis for patients with PABC is 32-38 years .A painless mass is palpated by the patient in 90% of reported cases .The incidence of breast cancer is the same in pregnant women as nonpregnant women in the general population.

Breast cancer is the most common malignancy affecting women world wide. More than one million cases diagnosed annually. One in ten of all new cancers diagnosed worldwide each year is a cancer of the female breast, and it is the most common cancer in women in both developing and developed areas. It is also the principal cause of death from cancer among women globally. Similar applied to Saudi Arabia. More over, cancer registry suggested an increase in incidence over the years with median age of 67 years old. The same applied for other Arab regions. Recently, women in Arab regions postpone their first pregnancy which may increase the risk for pregnancy associated breast cancer.

The physiologic changes that take place in the breast during pregnancy can contribute to a delay in the diagnosis of PABC. In preparation for lactation, a women's breast size will nearly double in size and weight. The influence of estrogen and progesterone cause an increase in blood flow and fat, resulting in an increase in the size of milk-producing glands. Some women may begin to leak colostrum by 25 weeks gestation. Irritation of the breast ducts caused by rapid tissue growth may cause a bloody discharge, which usually is a benign condition. The areola also may increase in size and become darker in color. In addition, Montgomery tubercles, small nodules surrounding the areola, will produce a fluid to lubricate and cleanse the nipple in preparation for nursing.

Breast cancer associated with pregnancy presents to the clinician with particular challenges at diagnosis and management level. The diagnosis may be delayed and difficult owing to the physiological changes within the breast and limitations on investigations. Moreover once a diagnosis has been confirmed and staging completed, options for treatment will be influenced by the need to give optimal treatment to the mother whilst minimizing risks to the fetus. The particular challenges faced both in the initial diagnosis and management of women with pregnancy-associated breast cancer will be assessed in this study.

Recent studies suggest that, when matched for age and stage, the prognosis of pregnancy-associated breast cancer is comparable to non-pregnancy-associated breast cancer. However, the risk for breast cancer recurrence associated with subsequent pregnancies in this population is not clear. Although there is data showing no increase in the risk of recurrence for women who become pregnant after breast cancer treatment, pregnancy-associated breast cancer may be a distinct clinical category where subsequent pregnancies after treatment may confer an increased risk of recurrent disease9.

There is a lack of controlled data concerning the management of pregnancy-associated breast cancer, both locally and globally.

Investigators plan in this study to assess and document the clinical presentation, diagnosis, treatment, prognostic factors, and routine clinical management of pregnant ladies diagnosed with breast cancer in Saudi Arabia. Data base through data collection on all information related to breast cancer patients with pregnancy will be performed across detailed interview and chart review at all specialized clinic in the National Guard. All patients seen within the coming 5 years will be enrolled in this study.

Investigators are interested to explore the clinical and pathological characteristics of breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during pregnancy, median gestational age at diagnosis, the level of the tumor differentiation patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan to collect prospective quality research databases that could provide further important information concerning this condition and serve in both short- and long-term sequelae in mother and fetus.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Riyadh, Saudi Arabien, 11426
        • Rekruttering
        • King Abdul Aziz Medical City for National Guard Health Affairs
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Omalkhair Abulkhair, MD

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

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study design approach is a cohort study, which planned to recruit all patients attend the breast cancer clinic, interview in details, assessed and followed prospectively for 5 years from the time of diagnoses or till death occurs, whichever occurred first.

Beskrivelse

Inclusion Criteria:

• All pregnants with breast cancer will be included in this study

Exclusion Criteria:

• Refusal of pregnant women with 2nd or 3rd trimester to receive chemotherapy, will be excluded

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
To explore the characteristics of pregnancy associated breast cancer (PABC), maternal and fetal outcome of the pregnancy.
Tidsramme: 5 years
5 years
Prevelance and outcome
Tidsramme: 5 years
• To determine the prevalence and incidence of breast cancer in pregnancy
5 years
prevalence and outcome
Tidsramme: 5 years
• To measure the prognostic outcomes of at mother and fetus level in breast cancer with pregnancy
5 years
prevalence and outcome
Tidsramme: 5 years
• To describe the pathological characteristics of breast cancer when it concomitantly present with pregnancy
5 years
prevalence and outcome
Tidsramme: 5 years
• To assess the sensitivity and specification of diagnostic procedure.
5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Long outcome
Tidsramme: 5 years
  • To measure the outcome of newborn after 1st and 5th year.
5 years
Long outcome
Tidsramme: 5 years
• To assess the outcome of breast cancer after 5 years from diagnosis
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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. november 2014

Primær færdiggørelse (Forventet)

1. november 2019

Studieafslutning (Forventet)

1. november 2019

Datoer for studieregistrering

Først indsendt

31. marts 2016

Først indsendt, der opfyldte QC-kriterier

12. maj 2016

Først opslået (Skøn)

17. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RC12/153/R

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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