Early Detection of Esophageal Cancer

NCT00341523 | Terminated

• 2 other identifiers: 999995026OH95-C-N026
• Study Type: observational
• Target: 6,864
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.The Mucosal Staining Study will evaluate whether mucosal straining can improve endoscopic localization of esophageal dysplasia and cancer.
3. 3.The Endoscopic Staging Study will evaluate how accurately endoscopic techniques can stage dysplasia and early invasive cancer of the esophagus.
4. 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. 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.

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Endoscopy, Gastrointestinal; Digestive System Endoscopic Surgical Procedures; Cytology

Keywords

Cytology; Endoscopy; Esophageal Cancer; Early Detection; Treatment; Natural History

Outcome Measures

Primary Outcomes (1)

• esophageal squamous dysplasia and cancer

  These case series studies have collected demographic and clinical data from medical records and patient questionnaires and have collected biological samples.

  single time point when samples are collected

Secondary Outcomes (2)

• Esophageal squamous cell carcinoma (ESCC)

  Clinical diagnosis of ESCC

• Death from any cause

  Death

Study Arms (1)

1

Chinese adults at high risk for esophageal cancer

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adults at high risk for esophageal cancer, and Chinese adults presenting with esophageal cancer in Linxian, China

You may qualify if:

• Resident of Linxian, Henan Province, People's Republic of China.
• 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).
• To be eligible at t(0), subjects must have a confirmed, endoscopically visible lesion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (3)

• Pan QJ, Roth MJ, Guo HQ, Kochman ML, Wang GQ, Henry M, Wei WQ, Giffen CA, Lu N, Abnet CC, Hao CQ, Taylor PR, Qiao YL, Dawsey SM. Cytologic detection of esophageal squamous cell carcinoma and its precursor lesions using balloon samplers and liquid-based cytology in asymptomatic adults in Llinxian, China. Acta Cytol. 2008 Jan-Feb;52(1):14-23. doi: 10.1159/000325430.

  PMID: 18323271 BACKGROUND

• Dawsey SM, Fleischer DE, Wang GQ, Zhou B, Kidwell JA, Lu N, Lewin KJ, Roth MJ, Tio TL, Taylor PR. Mucosal iodine staining improves endoscopic visualization of squamous dysplasia and squamous cell carcinoma of the esophagus in Linxian, China. Cancer. 1998 Jul 15;83(2):220-31.

  PMID: 9669803 BACKGROUND

• Taylor PR, Abnet CC, Dawsey SM. Squamous dysplasia--the precursor lesion for esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2013 Apr;22(4):540-52. doi: 10.1158/1055-9965.EPI-12-1347.

  PMID: 23549398 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Christian Abnet, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: November 1, 2016
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CN (1)