Outcome of Pregnancy and Breast Cancer (Pregnancy)
Outcome of Pregnancy Associated Breast Cancer (PABC) in Saudi Arabia ; Prospective Cohort Study.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Riyadh、サウジアラビア、11426
- 募集
- King Abdul Aziz Medical City for National Guard Health Affairs
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コンタクト:
- Omalkhair Abulkhair, MD
- 電話番号:141077 0096612520088
- メール:abulkhairo@ngha.med.sa
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コンタクト:
- Oncology Research
- 電話番号:14601 0096612520088
- メール:oncologyresearch@ngha.med.sa
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主任研究者:
- Omalkhair Abulkhair, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
To explore the characteristics of pregnancy associated breast cancer (PABC), maternal and fetal outcome of the pregnancy.
時間枠:5 years
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5 years
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Prevelance and outcome
時間枠:5 years
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• To determine the prevalence and incidence of breast cancer in pregnancy
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5 years
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prevalence and outcome
時間枠:5 years
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• To measure the prognostic outcomes of at mother and fetus level in breast cancer with pregnancy
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5 years
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prevalence and outcome
時間枠:5 years
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• To describe the pathological characteristics of breast cancer when it concomitantly present with pregnancy
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5 years
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prevalence and outcome
時間枠:5 years
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• To assess the sensitivity and specification of diagnostic procedure.
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5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Long outcome
時間枠:5 years
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5 years
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Long outcome
時間枠:5 years
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• To assess the outcome of breast cancer after 5 years from diagnosis
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5 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
乳がんの臨床試験
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