Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Perelman Center for Advanced Medicine
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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
Adult children of women born between 1945-1965 who have or have had hepatitis C Women born between 1945-1965 who have or have had hepatitis C
Investigators will only be recruiting subjects who are black or white as hepatitis C is most common in these two populations. Using these populations maximizes the generalizability of our results. HCV is not only significantly less common among Asian women and women of other races, but these women also represent a minority of the patient population at Penn.
説明
Inclusion Criteria:
Mothers:
- Born between 1/1/45-12/31/64
- Black or white race
- Active or prior infection with hepatitis C
- Have at least one living adult child over the age of 18
Children:
- ≥18 years of age
- Born to mother with current or prior HCV infection, with likely timing of HCV acquisition prior to or during pregnancy
- Mother gave informed consent for child to be approached for study participation
Exclusion Criteria:
Mothers:
- Unwilling to disclose hepatitis C status to children
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:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Mothers
Black or white mothers who have or have had hepatitis C and were born between 1945-1964.
Participants must have at least one child over the age of 18.
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Investigators will call eligible mothers to screen for the possibility that eligible mothers may have passed HCV on to adult children.
Investigators will consent these mothers to contact the adult child(ren), as the child(ren) must be informed of the mother's HCV status, if not already known.
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Adult Children
Adult children of Black or white mothers who have or have had hepatitis C and were born between 1945-1964.
From speaking with these mothers, it must be possible that participants were exposed to hepatitis C virus while in the womb.
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Adult children will be invited to Penn or a Penn affiliate to have labwork, testing HCV antibody and HCV quant.
If the quant comes back positive, investigators will also test genotype and fibrosure.
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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 |
|---|---|---|
|
HCV prevalence
時間枠:Within 1 week of labwork at first study visit
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Prevalence of HCV in adult children of female baby boomers who have or have had HCV
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Within 1 week of labwork at first study visit
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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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Liver fibrosis
時間枠:Within 2 weeks of diagnosis of HCV
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Level of liver fibrosis (detected through fibrosure test) found in adult children diagnosed as HCV-positive
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Within 2 weeks of diagnosis of HCV
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HCV genotype
時間枠:Within 6 weeks of diagnosis of HCV
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HCV genotype for adult children diagnosed as HCV-positive
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Within 6 weeks of diagnosis of HCV
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協力者と研究者
協力者
捜査官
- 主任研究者:David Goldberg, MD, MSCE、University of Pennsylvania
出版物と役立つリンク
一般刊行物
- Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, Patel N, Ward JW, Weinbaum CM. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012 Feb 21;156(4):263-70. doi: 10.7326/0003-4819-156-4-201202210-00378. Epub 2011 Nov 4.
- Voelker R. Birth cohort screening may help find hepatitis C cases. JAMA. 2012 Mar 28;307(12):1242. doi: 10.1001/jama.2012.337. No abstract available.
- AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.
- Benova L, Mohamoud YA, Calvert C, Abu-Raddad LJ. Vertical transmission of hepatitis C virus: systematic review and meta-analysis. Clin Infect Dis. 2014 Sep 15;59(6):765-73. doi: 10.1093/cid/ciu447. Epub 2014 Jun 13.
- Kuncio DE, Newbern EC, Johnson CC, Viner KM. Failure to Test and Identify Perinatally Infected Children Born to Hepatitis C Virus-Infected Women. Clin Infect Dis. 2016 Apr 15;62(8):980-5. doi: 10.1093/cid/ciw026. Epub 2016 Jan 20.
- Kabiri M, Jazwinski AB, Roberts MS, Schaefer AJ, Chhatwal J. The changing burden of hepatitis C virus infection in the United States: model-based predictions. Ann Intern Med. 2014 Aug 5;161(3):170-80. doi: 10.7326/M14-0095.
- Mast EE, Hwang LY, Seto DS, Nolte FS, Nainan OV, Wurtzel H, Alter MJ. Risk factors for perinatal transmission of hepatitis C virus (HCV) and the natural history of HCV infection acquired in infancy. J Infect Dis. 2005 Dec 1;192(11):1880-9. doi: 10.1086/497701. Epub 2005 Oct 28.
- Poynard T, Imbert-Bismut F, Munteanu M, Messous D, Myers RP, Thabut D, Ratziu V, Mercadier A, Benhamou Y, Hainque B. Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004 Sep 23;3(1):8. doi: 10.1186/1476-5926-3-8.
- Poynard T, Imbert-Bismut F, Munteanu M, Ratziu V. FibroTest-FibroSURE: towards a universal biomarker of liver fibrosis? Expert Rev Mol Diagn. 2005 Jan;5(1):15-21. doi: 10.1586/14737159.5.1.15.
- Patel K, Benhamou Y, Yoshida EM, Kaita KD, Zeuzem S, Torbenson M, Pulkstenis E, Subramanian GM, McHutchison JG. An independent and prospective comparison of two commercial fibrosis marker panels (HCV FibroSURE and FIBROSpect II) during albinterferon alfa-2b combination therapy for chronic hepatitis C. J Viral Hepat. 2009 Mar;16(3):178-86. doi: 10.1111/j.1365-2893.2008.01062.x. Epub 2008 Oct 24.
- Sebastiani G, Castera L, Halfon P, Pol S, Mangia A, Di Marco V, Pirisi M, Voiculescu M, Bourliere M, Alberti A. The impact of liver disease aetiology and the stages of hepatic fibrosis on the performance of non-invasive fibrosis biomarkers: an international study of 2411 cases. Aliment Pharmacol Ther. 2011 Nov;34(10):1202-16. doi: 10.1111/j.1365-2036.2011.04861.x. Epub 2011 Oct 9.
- Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
- Thein HH, Yi Q, Dore GJ, Krahn MD. Estimation of stage-specific fibrosis progression rates in chronic hepatitis C virus infection: a meta-analysis and meta-regression. Hepatology. 2008 Aug;48(2):418-31. doi: 10.1002/hep.22375.
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 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 826229
個々の参加者データ (IPD) の計画
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医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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