Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341523
Status:
TERMINATED
Last Update Posted:
2024-05-01
First Post:
2006-06-19
Brief Title:
Early Detection of Esophageal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Early Detection of Esophageal Cancer
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively closed by the IRBO
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 US universities
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 US universities
Detailed 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 eg 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 E6E7 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 E6E7 seropositivity as a marker of HPV-associated cancer
Asian esophageal cancer belt and human papillomavirus HPV has been proposed as a potential cause While several HPV-associated cancers have been identified eg 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 E6E7 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 E6E7 seropositivity as a marker of HPV-associated cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH95-C-N026 | None | None | None |