Esophageal NeoplasmsNCT00341523
Early Detection of Esophageal Cancer
An observational study of Esophageal Neoplasms and Stomach Neoplasms, run by National Cancer Institute (NCI) at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Esophageal Neoplasms, Stomach Neoplasms, Endoscopy, Gastrointestinal
- How many people
- 6,864 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2016to 29 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adults at high risk for esophageal cancer, and Chinese adults presenting with esophageal cancer in Linxian, China
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
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:
- The Cytology Sampling Study will estimate and compare the sensitivity of several cytologic samplers for identifying biopsy-proven dysplasia and cancer of the esophagus.
- The Mucosal Staining Study will evaluate whether mucosal straining can improve endoscopic localization of esophageal dysplasia and cancer.
- The Endoscopic Staging Study will evaluate how accurately endoscopic techniques can stage dysplasia and early invasive cancer of the esophagus.
- 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.
- 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.
Read the 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 (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.
- Conditions
- Esophageal Neoplasms, Stomach Neoplasms, Endoscopy, Gastrointestinal, Digestive System Endoscopic Surgical Procedures, Cytology
- Keywords
- Cytology, Endoscopy, Esophageal Cancer, Early Detection, Treatment, Natural History
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Chinese adults at high risk for esophageal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single time point when samples are collected
Secondary outcomes (2)
Esophageal squamous cell carcinoma (ESCC)
Measured: Clinical diagnosis of ESCC
Death from any cause
Measured: Death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Nov 2016
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Why it stopped: Administratively closed by the IRBO
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6,864 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christian Abnet, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341523
- Sponsor's protocol ID
- 999995026
- Other IDs
- OH95-C-N026
- Status last verified
- Apr 2024
- First submitted
- 19 Jun 2006
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18323271Dawsey 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.
PubMed 9669803Taylor 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.
PubMed 23549398
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00341523
- Acronym / sponsor ID
- 999995026
- Conditions
- Esophageal Neoplasms, Stomach Neoplasms, Endoscopy, Gastrointestinal, Digestive System Endoscopic Surgical Procedures, Cytology
- Keywords
- Cytology, Endoscopy, Esophageal Cancer, Early Detection, Treatment, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administratively closed by the IRBO
- Enrolment
- 6,864 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The Cytology Sampling Study will estimate and compare the sensitivity of several cytologic samplers for identifying biopsy-proven dysplasia and cancer of the esophagus.
- The Mucosal Staining Study will evaluate whether mucosal straining can improve endoscopic localization of esophageal dysplasia and cancer.
- The Endoscopic Staging Study will evaluate how accurately endoscopic techniques can stage dysplasia and early invasive cancer of the esophagus.
- 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.
- 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.
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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Chinese adults at high risk for esophageal cancer |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adults at high risk for esophageal cancer, and Chinese adults presenting with esophageal cancer in Linxian, China
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
esophageal squamous dysplasia and cancer
Time frame: single time point when samples are collected
These case series studies have collected demographic and clinical data from medical records and patient questionnaires and have collected biological samples.
2 secondary outcomes
Esophageal squamous cell carcinoma (ESCC)
Time frame: Clinical diagnosis of ESCC
Death from any cause
Time frame: Death
Results and safety
The study was stopped early (reason given: Administratively closed by the IRBO). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 18323271Pan 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.
- Background: PubMed 9669803Dawsey 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.
- Background: PubMed 23549398Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Abnet, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms and Stomach Neoplasms, run by National Cancer Institute (NCI) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administratively closed by the IRBO). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
esophageal squamous dysplasia and cancer (time frame: single time point when samples are collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.