Early Detection of Esophageal Cancer

Stomach Neoplasms Clinical Trial

Official title: Early Detection of Esophageal Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Esophageal squamous cell carcinoma (ESCC) is a major cause of death in the central

Asian esophageal cancer belt and human papillomavirus (HPV) has been proposed as a potential cause. While several HPV-associated cancers have been identified (e.g., cervical, tonsillar), the role of HPV in esophageal carcinogenesis remains unclear. Estimates of the prevalence of HPV in ESCC in Henan province, which lies in the central Asian esophageal cancer belt and of which Linxian is a part, have varied from 0-78%. Contamination of specimens may contribute to this variation, as may differences in HPV detection techniques. With the imminent availability of an effective HPV vaccine, it is critical to determine if HPV is or is not involved in ESCC in Linxian given the potential for cancer prevention through use of the

vaccine if HPV is involved. OBJECTIVES: The overall objective is to test the hypothesis that HPV is involved in the pathogenesis of ESCC in Linxian, China.

We will 1) determine the prevalence of HPV DNA in ESCC tumors and 2) evaluate the activity of HPV in HPV DNA-positive cases.

ELIGIBILITY:

This study will be conducted among adult patients with ESCC presenting for esophagectomy at Yaocun Commune Hospital in Linxian, China.

DESIGN: This case series study will collect demographic and clinical data from medical records and will use rigorous sterile procedures to obtain biologic specimens (blood, tumor, nontumor) from patients with ESCC. The presence of HPV DNA in tumor specimens will be evaluated using PCR with L1, E6, and E7-based primers. The activity of HPV in HPV DNA-positive cases will be assessed by immunohistochemistry for p16 (ink4a) over-expression, RT-PCR for E6/E7 mRNA expression, and amplification of papillomavirus oncogene transcripts (APOT) for HPV integration in tumor specimens. Nontumor specimens will also be examined for the presence of HPV DNA, and serum will be tested for HPV 16 and HPV 18 E6/E7 seropositivity as a marker of HPV-associated cancer. ;

Related Conditions & MeSH terms

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

• NCT number: NCT00341523
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Terminated
• Start date: November 1, 2016
• Completion date: April 29, 2024