Early Detection of Esophageal Cancer


N/A
40 Years
69 Years
Open (Enrolling)
Both
Esophageal Cancer

Thank you

Trial Information

Early Detection of Esophageal Cancer


BACKGROUND:

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, non-tumor)
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. Non-tumor 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.

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Sanford M Dawsey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999995026

NCT ID:

NCT00341523

Start Date:

May 1994

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Cytology
  • Endoscopy
  • Endoscopic Therapy
  • Endoscopic Ultrasonography
  • Mucosal Staining
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location