Trial Title:
Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer
NCT ID:
NCT06306755
Condition:
Esophageal Cancer
Gastric Cancer
Precision Screening
Sequential Screening
Risk Stratification
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Risk Assessment and Individualized Surveillance
Description:
1. An epidemiological questionnaire-based risk assessment for UGIC conducted prior to
the endoscopic examination;
2. Individuals identified as "high-risk" receive the upper gastrointestinal endoscopic
examination with Lugol's Iodine in the esophagus and indigo carmine staining in the
stomach;
3. Individualized reexamination and surveillance strategy will be given to participants
diagnosed with premalignant lesions, based on evaluation of risk progression using
endoscopic characteristics, pathological diagnosis, and biomarkers.
Arm group label:
Sequential screening group
Intervention type:
Procedure
Intervention name:
Universal screening
Description:
1. A questionnaire investigation;
2. All participants undergo the upper gastrointestinal endoscopic examination with
Lugol's Iodine in the esophagus and indigo carmine staining in the stomach;
3. Reexamination and surveillance will be performed according to the current guidelines
for UGIC screening and clinical treatment.
Arm group label:
Universal screening group
Summary:
To evaluate the feasibility, applicability, effectiveness, and health-economic value of
the risk-based sequential screening modality for esophageal and gastric cancers, the
investigators aim to initiate a community-based randomized controlled trial in Xun
County, Henan Province, which is a high-risk region of upper gastrointestinal cancer
(UGIC) in northern China.
A total of 258 target villages from all the 11 communities (townships and streets) in Xun
County will be randomly selected and assigned to the sequential screening group and the
universal screening group at a ratio of 2:1 and the total sample size will be 21,000.
In the sequential screening group, participants in the top 50% risk level (i.e.,
stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal
endoscopic screening. In contrast, all participants in the universal screening group will
receive the endoscopic examination. The surveillance strategy for participants with
screening-detected premalignant lesions in the sequential screening group will be
tailored based on individualized risk assessment using endoscopic characteristics,
pathological diagnosis, and biomarkers. Surveillance for participants in the universal
screening group will adhere to current guidelines for UGIC screening and clinical
treatment.
Detection rates of upper gastrointestinal malignant lesions, early-stage malignant
lesions and premalignant lesions, and health-economic indicators such as the unit cost
per detected malignant lesions will be compared between the two groups.
Detailed description:
A series of challenges have arisen for the current UGIC screening modality in China,
including high screening costs, low detection rates, delayed and unstandardized
treatment, and lack of sustainability and scalability. These challenges significantly
hinder the normalization and high-quality implementation of UGIC prevention and control
efforts. The precision shift in the screening modality is expected to result in
substantial savings in medical resources while maximizing the identification and
management of high-risk populations.
The investigators aim to initiate a community-based randomized controlled trial to
evaluate the effectiveness of risk-based sequential screening for esophageal and gastric
cancer (ERSS-EGC trial) in Xun County of Henan Province, which is a high-risk region of
UGIC in northern China.
According to the baseline data obtained from our prior UGIC screening program conducted
in the same region (He et al., Gut, 2019), the detection rate of upper gastrointestinal
malignant lesions in the targeted population (aged 50-69 years) in the universal
screening group is estimated to be 1.1%. It is assumed that the implementation of
sequential screening will increase this detection rate by 70%, indicating an expected
detection rate of 1.9% for upper gastrointestinal malignant lesions in the sequential
screening group. Ultimately, a total of 7,674 endoscopies (with 3,837 in each group) will
be required to achieve a statistical power of 80% at a one-sided significance level of
2.5%.
Based on the estimated population coverage determined by sample size, a total of 258
target villages from all the 11 communities (townships and streets) in Xun County will be
randomly selected, stratified by townships and streets. These 258 target villages will be
randomly assigned to either the sequential screening group or the universal screening
group at a ratio of 2:1, based on the population size of each village and stratified by
region (urban and rural areas). This results in 172 villages in the sequential screening
group and 86 villages in the universal screening group. Approximately 21,000 permanent
residents aged 50 to 69 residing in the target villages will be enrolled in the trial.
All enrolled eligible participants will receive an epidemiological questionnaire
investigation (collecting data on basic information, dietary habits, environmental
exposure, family history, symptoms, quality of life, etc.), and a physical examination.
In the sequential screening group, all enrolled participants will be offered a risk
assessment for esophageal and gastric malignancies based on two questionnaire-based
diagnostic models (Liu et al., Cancers, 2022, 14(23):5945; Zheng et al., Chin Med J
(Engl), 2024). Participants identified as "high-risk" (i.e., with a top 50% risk level)
for esophageal and/or gastric malignancy will receive the standard upper gastrointestinal
endoscopy. Standardized diagnosis and treatment recommendations will be provided to
patients with screening-detected malignant lesions, and green referral channels will be
established for them. For participants with screening-detected premalignant lesions, the
risk of progression will be evaluated based on endoscopic characteristics, pathological
diagnosis, and biomarkers. Individualized reexamination and surveillance will be
implemented accordingly.
In the universal screening group, all enrolled participants will receive the same
standard upper gastrointestinal endoscopy as those in the sequential screening group,
irrespective of the results of the risk assessment. Standardized diagnosis and treatment
recommendations will be provided to patients with screening-detected malignant lesions,
and green referral channels will be established for them. For participants with
screening-detected premalignant lesions, the reexamination and surveillance will be
performed according to the current guidelines for UGIC screening and clinical treatment.
The primary outcome of this study is the detection rate of upper gastrointestinal
(esophageal/gastric) malignant lesions. The secondary outcomes include the rate of
early-stage upper gastrointestinal (esophageal/gastric) malignant lesions, detection rate
of upper gastrointestinal (esophageal/gastric) premalignant lesions, response rate of
endoscopic examination, total screening costs, unit cost per detected upper
gastrointestinal malignant lesions, unit cost per detected early-stage upper
gastrointestinal malignant lesions, unit cost per detected upper gastrointestinal
premalignant lesions, satisfaction of project executors and participants, rate of timely
treatment, UGIC-specific mortality, all-cause mortality, and quality of life.
Through a comprehensive comparison with the universal screening, this trial will provide
high-level evidence regarding the feasibility, applicability, effectiveness, and
health-economic value of the sequential screening modality. Furthermore, it could
effectively facilitate standardized diagnosis and treatment for screening-detected
patients, providing crucial practical experience and scientific evidence for the reform
and development of secondary prevention strategies for UGIC in China.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Permanent residency in the target villages in Xun County, Henan Province, China;
- Aged 50 to 69 at the enrollment;
- Voluntarily participate in this study and provide informed consent.
Exclusion Criteria:
- Had a history of endoscopic examination within 5 years prior to the initial
interview;
- Had a history of cancer;
- Had a history of mental disorder;
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human
immunodeficiency virus (HIV);
- Had severe cardiovascular and cerebrovascular diseases;
- Had severe respiratory disease, dyspnea, or asthmaticus status;
- Had retropharyngeal abscess, severe spinal deformity, or aortic aneurysm;
- With physical debility unable to tolerate endoscopic examination, or with difficulty
in achieving sedation and self-control;
- In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or
with suspected perforation of the upper gastrointestinal tract;
- Had massive ascites, severe abdominal distension, or severe esophageal varices;
- Pregnancy;
- Had severe history of allergies;
- Had propensity for bleeding (coagulopathy);
- Others unable to tolerate the clinical examinations involved in this study.
Gender:
All
Minimum age:
50 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of genetics, Peking University Cancer Hospital & Institute
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhonghu He
Email:
zhonghuhe@bjcancer.org
Investigator:
Last name:
Zhonghu He, PhD
Email:
Principal Investigator
Start date:
June 25, 2024
Completion date:
December 2034
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06306755