TerminatedNot Applicable

Early Detection of Esophageal Cancer

Stopped: Administratively closed by the IRBO

China6,864 participantsStarted 2016-11-01

Plain-language summary

Esophageal cancer is a common malignancy with a very poor prognosis. The principal reason for its poor prognosis is that most tumors are asymptomatic and go undetected until they have spread beyond the esophageal wall and are unresectable. Significant reduction in esophageal cancer mortality will require successful strategies to diagnose and treat more cases at earlier, more curable stages of disease. A successful early detection program will require an accurate, patient-acceptable screening test, confirmatory tests that can localize precursor and early invasive lesions, and one or more curative therapies that are acceptable to asymptomatic patients. This project includes five studies designed to evaluate techniques that may be useful in such an early detection program: 1. The Cytology Sampling Study will estimate and compare the sensitivity of several cytologic samplers for identifying biopsy-proven dysplasia and cancer of the esophagus. 2. The Mucosal Staining Study will evaluate whether mucosal straining can improve endoscopic localization of esophageal dysplasia and cancer. 3. The Endoscopic Staging Study will evaluate how accurately endoscopic techniques can stage dysplasia and early invasive cancer of the esophagus. 4. The Endoscopic Therapy Pilot Study will evaluate the feasibility, safety, acceptability and preliminary efficacy of endoscopic therapies for removing or ablating focal high-grade dysplasias and early invasive cancers of the esphagus. 5. The Chemoregression Study will evaluate the ability of oral chemopreventive agents to reduce progression or cause regression of low-grade squamous dysplasia of the esophagus. This project will be carried out in Linxian, China, a county with extraordinary rates of esophageal cancer and a correspondingly high prevalence of the asymptomatic precursor and early invasive lesions that are needed for these studies. The project will be a collaborative effort of investigators from NCI, the Cancer Institute of the Chinese Academy of Medical Sciences, and several U.S. universities.

Who can participate

Age range21 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Resident of Linxian, Henan Province, People's Republic of China. 40-69 years of age at the time of EGD screening. Visible esophageal lesions with mild or moderate squamous dysplasia found at the t(-6) EGD screening exam. Confirmation of a visible index lesion at the t(0)EGD baseline exam. Willing to abstain from chronic NSAID use (defined as greater than 3 times per week for more than 2 weeks), with the exception of low-dose aspirin (less than or equal to 100 mg per day), for the duration of the study. If a subject is female and of child-bearing potential (premenopausal or less than 2 years postmenopausal and not surgically sterile), she must be willing to use adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) for the duration of the study. Appropriate laboratory values within 2 weeks of the baseline evaluation for: hemoglobin greater than 11.0 g/dl; WBC greater than 3000/mm(3); platelet count greater than 100,000; creatinine less than or equal to 1.5 times the upper limit of normal; AST less than or equal to 1.5 times the upper limit of normal; Alkaline phosphatase less than or equal to 1.5 the upper limit of normal; Pregnancy test negative serum or urine (women of childbearing potential only). Only those patients with mild or moderate dysplasia based on the t(-6) histology and endoscopically visible lesions at the t(0) evaluation will be eligible for participation and inclusion in t…

What they're measuring

esophageal squamous dysplasia and cancer

Timeframe: single time point when samples are collected

Trial details

NCT IDNCT00341523

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2024-04-29