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Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this double-blind, randomized controlled clinical trial. Research project is planned to recruit 10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China, which has been known as a high incidence region of ESCC. All the participants receive endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained lesions (USLs). The location and size of each USL will be recorded followed by collecting biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six months and the second at 3 or 5 years later). The primary outcome measure was occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the participants and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental |
| |
| Tea Polyphenols | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 100mg qd for 6 months. |
| |
| Tea Polyphenols |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of high grade dysplasia and invasive ESCC | at six months |
| Measure | Description | Time Frame |
|---|---|---|
| the mortality of the participants | The first interval will be at six months and the second at 3 or 5 years later. | |
| Number of participants with adverse events. | The first interval will be at six months and the second at 3 or 5 years later. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu-Tian Zhang, MD | Contact | +86 010 63138067 | drzstbj@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shu-Tian Zhang, MD | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital Capital Medical University | Beijing | 100050 | China |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Dietary Supplement |
300mg bid for 6 months. |
|
| occurrence of high grade dysplasia and invasive ESCC | at 3 or 5 years later |
| D018307 |
| Neoplasms, Squamous Cell |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |