Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.
Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.
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皮肤恶性黑色素瘤结果（VIDME）中补充维生素D：一项随机对照试验。
DOI：
10.1186/s12885-017-3538-4
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发表时间：
2017-08-23
期刊：
影响因子：
3.8
通讯作者：
Garmyn M
中科院分区：
文献类型：
--
作者：
De Smedt J;Van Kelst S;Boecxstaens V;Stas M;Bogaerts K;Vanderschueren D;Aura C;Vandenberghe K;Lambrechts D;Wolter P;Bechter O;Nikkels A;Strobbe T;Emri G;Marasigan V;Garmyn M
先前的研究调查了诊断时和治疗后随访期间维生素 D 血清水平对黑色素瘤结局的保护作用。在本研究中，我们评估了在原发肿瘤诊断和手术切除后的随访期间补充维生素 D 是否对皮肤恶性黑色素瘤的复发具有保护作用，以及这种保护作用是否与血清中的维生素 D 水平和原发肿瘤中的维生素 D 受体免疫反应性相关。本研究是一项多中心随机双盲安慰剂对照 III 期试验。年龄在 18 岁至 80 岁之间、经诊断并接受 IB-III 期黑色素瘤手术治疗的患者有资格以 1:1 的比例随机分组，接受积极治疗或安慰剂。该研究药物每月服用一次，由 100,000 国际单位胆钙化醇或用作安慰剂的花生油组成。主要终点是无复发生存期。次要终点是诊断时和每隔 6 个月的 25 羟基维生素 D3 血清水平、黑色素瘤亚型、黑色素瘤部位和诊断时黑色素瘤分期（根据 2009 年美国癌症联合委员会黑色素瘤分期和分类）。随机抽取血样进行 DNA 分析。该研究得到了当地伦理委员会的批准。如果我们能够证实我们的假设，即肿瘤切除后补充维生素 D 对皮肤恶性黑色素瘤的复发具有保护作用，我们可能会在多个层面上减轻 CMM 的负担。诊断出黑色素瘤的患者可能会获得更好的临床结果并提高生活质量。与转移性疾病治疗相关的医疗费用将会减少，职业年限也会减少，这将显着减轻疾病的经济负担。临床试验.gov，NCT01748448，05/12/2012
Previous studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and Vitamin D Receptor immunoreactivity in the primary tumor. This study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees. If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease. Clinical Trial.gov, NCT01748448, 05/12/2012
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影响因子：
3.6
作者：
Sage, Robert J.;Lim, Henry W.
通讯作者：
Lim, Henry W.
影响因子：
168.9
作者：
Wang, Thomas J.;Zhang, Feng;Richards, J. Brent;Kestenbaum, Bryan;van Meurs, Joyce B.;Berry, Diane;Kiel, Douglas P.;Streeten, Elizabeth A.;Ohlsson, Claes;Koller, Daniel L.;Peltonen, Leena;Cooper, Jason D.;O'Reilly, Paul F.;Houston, Denise K.;Glazer, Nicole L.;Vandenput, Liesbeth;Peacock, Munro;Shi, Julia;Rivadeneira, Fernando;McCarthy, Mark I.;Anneli, Pouta;de Boer, Ian H.;Mangino, Massimo;Kato, Bernet;Smyth, Deborah J.;Booth, Sarah L.;Jacques, Paul F.;Burke, Greg L.;Goodarzi, Mark;Cheung, Ching-Lung;Wolf, Myles;Rice, Kenneth;Goltzman, David;Hidiroglou, Nick;Ladouceur, Martin;Wareham, Nicholas J.;Hocking, Lynne J.;Hart, Deborah;Arden, Nigel K.;Cooper, Cyrus;Malik, Suneil;Fraser, William D.;Hartikainen, Anna-Liisa;Zhai, Guangju;Macdonald, Helen M.;Forouhi, Nita G.;Loos, Ruth J. F.;Reid, David M.;Hakim, Alan;Dennison, Elaine;Liu, Yongmei;Power, Chris;Stevens, Helen E.;Jaana, Laitinen;Vasan, Ramachandran S.;Soranzo, Nicole;Bojunga, Joerg;Psaty, Bruce M.;Lorentzon, Mattias;Foroud, Tatiana;Harris, Tamara B.;Hofman, Albert;Jonsson, John-Olov;Cauley, Jane A.;Uitterlinden, Andre G.;Gibson, Quince;Jarvelin, Marjo-Riitta;Karasik, David;Siscovick, David S.;Econs, Michael J.;Kritchevsky, Stephen B.;Florez, Jose C.;Todd, John A.;Dupuis, Josee;Hyppoenen, Elina;Spector, Timothy D.
通讯作者：
Spector, Timothy D.
影响因子：
45.3
作者：
Balch, Charles M.;Gershenwald, Jeffrey E.;Sondak, Vernon K.
通讯作者：
Sondak, Vernon K.
影响因子：
45.3
作者：
Newton-Bishop, Julia A.;Beswick, Samantha;Bishop, D. Timothy
通讯作者：
Bishop, D. Timothy
DOI：
10.1093/jnci/95.11.806
发表时间：
2003-06-04
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
Whiteman, DC;Watt, P;Green, AC
通讯作者：
Green, AC