Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients
Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients: A Multicenter Retrospective Study
調査の概要
詳細な説明
Breast cancer is one of the most common malignant tumors in women, and the incidence rate is gradually increasing, accounts for the first place in the incidence of female malignant tumors. Bone metastasis is the most common distant metastatic site for breast cancer, accounting for approximately 70% of all patients with advanced breast cancer. About 26%-50% of breast cancer patients with primary metastases are bone. Autopsy results showed that the overall incidence of breast cancer bone metastasis was about 47%-85%.
Postoperative routine screening for bone metastases in breast cancer patients, whether domestic or foreign, is not recommended in most guidelines. These recommendations were based on two prospective randomized controlled trials in Italy in 1990s, indicated that a bone scan every six months or annually didn't provide a survival benefit to the patient. However, there were researches showing that about 11% of patients with asymptomatic breast cancer have bone metastases, suggesting that early screening might detect more patients with asymptomatic bone metastases. The meta-analysis also pointed out that early screening may prolong the disease-free survival of patients. Besides, the imaging techniques have advance rapidly and remarkably since then. New trials are needed to figure out whether imaging screening of asymptomatic patients should be routinely performed to detect more asymptomatic bone metastases needs further investigation.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100044
- Peking University People's Hospital
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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:
A. Histologically proven breast cancer confirmed by biopsy or pathological examination of the resected tumor.
B. Histologically confirmed breast cancer patients, fulfilling any of the following:
- . Multiple bone metastases indicated by bone scan
- . Bone scan positive, and proven by other imaging examinations, including computed tomography (CT), magnetic resonance imaging (MRI) and X-ray.
- . Bone scan positive, with clinical symptoms, including bone pain, pathologic fracture, spinal cord compression and so on.
- . Bone metastases indicated by PET-CT
- . Histologically proven bone metastases
Exclusion Criteria:
A. No bone metastases confirmed by pathological examination B. Bone metastases secondary to other malignant tumor other than breast cancer C. Secondary primary tumor
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
- 観測モデル:コホート
- 時間の展望:回顧
コホートと介入
グループ/コホート |
介入・治療 |
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Bone metastasis screening
The information about bone metastasis screening is retrospectively collected.
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Recommendation and results of bone imaging such as bone scan or PET/CT, or bone CT /MR are collected.
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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 |
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Overall survival
時間枠:60 months, and bone scan is repeated every 12 months
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defined as the period from randomization to death from any cause, and it is censored at the last follow-up date when the patient is alive
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60 months, and bone scan is repeated every 12 months
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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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disease-free survival
時間枠:60 months, and bone scan is repeated every 12 months
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defined as time to disease recurrence (invasive local, regional, or distant metastasis) or death from any cause
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60 months, and bone scan is repeated every 12 months
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distant metastasis-free survival
時間枠:60 months, and bone scan is repeated every 12 months
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defined as time to distant metastasis
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60 months, and bone scan is repeated every 12 months
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Rojas MP, Telaro E, Russo A, Moschetti I, Coe L, Fossati R, Palli D, del Roselli TM, Liberati A. Follow-up strategies for women treated for early breast cancer. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001768. doi: 10.1002/14651858.CD001768.pub2.
- Khatcheressian JL, Hurley P, Bantug E, Esserman LJ, Grunfeld E, Halberg F, Hantel A, Henry NL, Muss HB, Smith TJ, Vogel VG, Wolff AC, Somerfield MR, Davidson NE; American Society of Clinical Oncology. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Mar 1;31(7):961-5. doi: 10.1200/JCO.2012.45.9859. Epub 2012 Nov 5.
- Rosselli Del Turco M, Palli D, Cariddi A, Ciatto S, Pacini P, Distante V. Intensive diagnostic follow-up after treatment of primary breast cancer. A randomized trial. National Research Council Project on Breast Cancer follow-up. JAMA. 1994 May 25;271(20):1593-7. doi: 10.1001/jama.271.20.1593.
- Impact of follow-up testing on survival and health-related quality of life in breast cancer patients. A multicenter randomized controlled trial. The GIVIO Investigators. JAMA. 1994 May 25;271(20):1587-92. doi: 10.1001/jama.1994.03510440047031.
- Palli D, Russo A, Saieva C, Ciatto S, Rosselli Del Turco M, Distante V, Pacini P. Intensive vs clinical follow-up after treatment of primary breast cancer: 10-year update of a randomized trial. National Research Council Project on Breast Cancer Follow-up. JAMA. 1999 May 5;281(17):1586. doi: 10.1001/jama.281.17.1586. No abstract available.
- Gradishar WJ, Anderson BO, Balassanian R, Blair SL, Burstein HJ, Cyr A, Elias AD, Farrar WB, Forero A, Giordano SH, Goetz M, Goldstein LJ, Hudis CA, Isakoff SJ, Marcom PK, Mayer IA, McCormick B, Moran M, Patel SA, Pierce LJ, Reed EC, Salerno KE, Schwartzberg LS, Smith KL, Smith ML, Soliman H, Somlo G, Telli M, Ward JH, Shead DA, Kumar R. Invasive Breast Cancer Version 1.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 Mar;14(3):324-54. doi: 10.6004/jnccn.2016.0037.
- Yong M, Jensen AO, Jacobsen JB, Norgaard M, Fryzek JP, Sorensen HT. Survival in breast cancer patients with bone metastases and skeletal-related events: a population-based cohort study in Denmark (1999-2007). Breast Cancer Res Treat. 2011 Sep;129(2):495-503. doi: 10.1007/s10549-011-1475-5. Epub 2011 Apr 2.
- Gong Y, Liu YR, Ji P, Hu X, Shao ZM. Impact of molecular subtypes on metastatic breast cancer patients: a SEER population-based study. Sci Rep. 2017 Mar 27;7:45411. doi: 10.1038/srep45411.
- Xiong Z, Deng G, Huang X, Li X, Xie X, Wang J, Shuang Z, Wang X. Bone metastasis pattern in initial metastatic breast cancer: a population-based study. Cancer Manag Res. 2018 Feb 9;10:287-295. doi: 10.2147/CMAR.S155524. eCollection 2018.
- Zhang H, Zhu W, Biskup E, Yang W, Yang Z, Wang H, Qiu X, Zhang C, Hu G, Hu G. Incidence, risk factors and prognostic characteristics of bone metastases and skeletal-related events (SREs) in breast cancer patients: A systematic review of the real world data. J Bone Oncol. 2018 Feb 3;11:38-50. doi: 10.1016/j.jbo.2018.01.004. eCollection 2018 Jun.
- Coleman R, de Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, von Minckwitz G, Sleeboom HP, Forbes J, Barrios C, Frassoldati A, Campbell I, Paija O, Martin N, Modi A, Bundred N. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013 Feb;24(2):398-405. doi: 10.1093/annonc/mds277. Epub 2012 Oct 9.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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乳がんの臨床試験
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Intensive screening / routine screeningの臨床試験
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Washington State UniversityNational Institute on Drug Abuse (NIDA)完了
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Shahid Beheshti University of Medical Sciences完了
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University Hospital, Basel, SwitzerlandSwiss National Science Foundation募集