Early Detection of Esophageal Cancer
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||May 1, 2013|
|Start Date ICMJE||May 1994|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00341523 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Early Detection of Esophageal Cancer|
|Official Title ICMJE||Early Detection of Esophageal Cancer|
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:
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.
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.
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.
This study will be conducted among adult patients with ESCC presenting for esophagectomy at Yaocun Commune Hospital in Linxian, China.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Esophageal Cancer|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||8000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Ages||40 Years to 69 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||China|
|NCT Number ICMJE||NCT00341523|
|Other Study ID Numbers ICMJE||999995026, OH95-C-N026|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP