中山市におけるEBV関連バイオマーカーを用いた上咽頭がんのスクリーニング
中山市における上咽頭がんの早期発見バイオマーカーの探索
The study includes two cohorts: (1) a serological screening cohort; (2) a serological and EBV DNA screening cohort. All participants will be tested for EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab), with additional plasma EBV DNA testing in the latter cohort. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
調査の概要
状態
条件
詳細な説明
Sample selection
- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
- Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
- Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
- At initial screening, all participants in both cohorts will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in the serological and EBV DNA screening cohort, EBV-DNA will be tested. Consecutive EBV DNA positivity is defined as positive plasma EBV DNA results at both baseline and repeat testing approximately 4 weeks later. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or consecutive EBV DNA positive. The rest will be screening negative.
- During the initial screening and following up, people with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
- Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
- EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
- The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
- All subjects will also be followed by record linkage to Cancer Register and Population Register.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Mingfang Ji, MD
- 電話番号：86-760-89880417
- メール：jmftbh@sina.com
研究場所
-
-
Guangdong
-
Zhongshan、Guangdong、中国、528403
- 募集
- Zhongshan People's Hospital
-
コンタクト：
- Mingfang Ji, MD
- メール：jmftbh@sina.com
-
主任研究者：
- Mingfang Ji, MD
-
-
Guangxi
-
Wuzhou、Guangxi、中国、543002
- 募集
- Wuzhou Red Cross Hospital
-
コンタクト：
- Yonglin Cai, MD
- メール：cylzen@hotmail.com
-
主任研究者：
- Yonglin Cai, MD
-
-
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
30-69 years old healthy residences in Zhongshan City and Wuzhou City.
説明
Inclusion Criteria:
- Subject residents in Zhongshan City or Wuzhou City
- Subject has no medical record of nasopharyngeal carcinoma
- ECOG 0-2
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
Exclusion Criteria:
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
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：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Serological screening cohort
30-69 years old healthy participants. |
Collect blood and saliva samples from participants Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy |
|
Serological and EBV DNA screening cohort
30-69 years old healthy participants. |
Collect blood and saliva samples from participants Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy All participants undergo baseline EBV DNA testing. Those with positive results are invited for repeat testing approximately 4 weeks later. Consecutive positivity is defined as positive results at both tests. |
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 |
|---|---|---|
|
Sensitivity and specificity of different EBV associated biomarkers
時間枠：5 years
|
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC |
5 years
|
|
Positive and negative predictive values of different EBV associated biomarkers
時間枠：5 years
|
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC |
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number needed to screen to identify one nasopharyngeal carcinoma
時間枠：5 years
|
To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers |
5 years
|
|
Early diagnosis rate of nasopharyngeal carcinoma
時間枠：5 years
|
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma |
5 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The health economic benefits of different biomarkers for nasopharyngeal carcinoma
時間枠：5 years
|
To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers |
5 years
|
|
New screening strategy of nasopharyngeal carcinoma screening
時間枠：5 years
|
Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma |
5 years
|
協力者と研究者
捜査官
- 主任研究者：Mingfang Ji, MD、Zhongshan People's Hospital, Guangdong, China
出版物と役立つリンク
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 (推定)
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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