Overview

This trial was last updated 3 days ago.
Conditions esophageal neoplasms, stomach neoplasms, endoscopy, gastrointestinal, digestive system endoscopic surgical procedures, cytology
Sponsor National Cancer Institute (NCI)
Start date May 1994
Trial size 8000 participants
Trial identifier NCT00341523, 999995026, NCT00005885, OH95-C-N026

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries China

Study Design

Time perspective prospective

Primary Outcomes

Measure
Esophageal squamous dysplasia
time frame: Single time point, when samples are collected

Secondary Outcomes

Measure
Esophageal squamous cell carcinoma (ESCC)
time frame: Clinical diagnosis of ESCC
Death from any cause
time frame: Death

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

- 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 the study. To be eligible at t(0), subjects must have a confirmed, endoscopically visible lesion. EXCLUSION CRITERIA: Diagnosed cancer at any site, except non-melanoma skin cancer. Current symptoms suggestive of an upper gastrointestinal tract malignancy, including dysphagia, odynophagia, hematemesis, or weight loss of greater than 10% body weight within the past 6 months. Contraindications to the EGD exams, including hypersensitivity to lidocaine or iodine, uncontrolled congestive heart failure, unstable angina, bleeding disorder or severe pulmonary disease. Contraindications to use of the intervention agents, including hypersensitivity to selenomethionine, COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides. Treated for peptic ulcer disease within the past month prior to the baseline evaluation. Acute or chronic kidney disease, liver disease, or asthma. Pregnant or nursing an infant. Other serious health condition that might preclude study completion (at the discretion of the investigators). Currently using fluconazole or lithium.

Additional Information

Official title Early Detection of Esophageal Cancer
Principal investigator Sanford M Dawsey, M.D.
Description 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 six 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 staining 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 esophagus. 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. 6. The Human Papillomavirus Tissue Study will evaluate the hypothesis that HPV is involved in the pathogenesis of esophageal squamous cell carcinoma and/or gastric cardia adenocarcinoma. 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, and the Cancer Institute of the Chinese Academy of Medical Sciences.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC).