GASTROINTESTINAL NEOPLASMSNCT06509022
Longitudinal Study on the Evolution Trend and Influencing Factors of Postoperative Reflux of Esophageal Cancer Based on PEPTEST Technique
An observational study of GASTROINTESTINAL NEOPLASMS, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this observational study intends to explore the evolution trend and related factors of postoperative reflux of esophageal cancer based on PEPTEST detection, in order to identify postoperative reflux The main question it aims to answer are: to provide evidence for high-risk groups, improvement of surgical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GASTROINTESTINAL NEOPLASMS
- What is being tested?
- PEPTEST test
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent resection for esophageal cancer were continuously enrolled.
Who may be able to join
- Patients who were pathologically diagnosed with esophageal cancer and underwent esophagectomy for esophageal cancer.
- The patient can communicate in Mandarin.
- Those who can come to the hospital for review on time.
Who cannot join
- People with cognitive impairment or mental illness.
- Complicating other serious life-threatening diseases (such as leukemia or autoimmune diseases).
- Unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: China Cancer Foundation Beijing Hope Marathon Fund
The goal of this observational study intends to explore the evolution trend and related factors of postoperative reflux of esophageal cancer based on PEPTEST detection, in order to identify postoperative reflux
The main question it aims to answer are:
Read more
to provide evidence for high-risk groups, improvement of surgical methods for esophageal cancer, and development of health education programs to prevent postoperative reflux.
Using convenient sampling method, patients undergoing esophagectomy in thoracic surgery Department of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 were continuously enrolled. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery.
The incidence of pathological reflux at 5 time points before and after surgery was observed and compared (that is, both T-line and C-line were shown). The trend of pepsin content in saliva before and after operation; The relationship between pathological reflux and surgical factors; The relationship between pathological reflux and life habits after operation; Relationship between pathological regurgitation and demographic characteristics.
Read the detailed description
The subjects of this study were selected from the patients who underwent esophagectomy in the Department of Thoracic Surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 to December 1, 2023, and the patients who underwent esophagectomy in the Department of thoracic surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. To describe the evolution trend of postoperative reflux in patients with esophageal cancer can be used for anticipatory sexual health education. To explore the relevant factors of reflux: to identify the inherent factors, such as gender, BMI, etc., to give preventive intervention to high-risk groups; The variable factors such as the length and width of the tube stomach can be improved.
- Conditions
- GASTROINTESTINAL NEOPLASMS
- Being tested
- PEPTEST test
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPTEST testDiagnostic test
Quantitative determination of gastric salivary amylase。
| Study group | Role | What they receive |
|---|---|---|
| Before surgery | A patient with esophageal cancer before surgery Receives: Diagnostic Test: PEPTEST test | |
| Before discharge | Patients with esophageal cancer who were not discharged after surgery Receives: Diagnostic Test: PEPTEST test | |
| 1 month after surgery | One month after surgery for esophageal cancer Receives: Diagnostic Test: PEPTEST test | |
| 3 months after surgery | Three months after surgery for esophageal cancer Receives: Diagnostic Test: PEPTEST test | |
| 6 months after surgery | Six months after surgery for esophageal cancer Receives: Diagnostic Test: PEPTEST test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pathological regurgitation
Incidence of pathological regurgitation at 5 time points before and after surgery.
Measured: 2023.1.1-2023.12.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GASTROINTESTINAL NEOPLASMSStudies of the same condition, open and under way.
- 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509022
- Sponsor's protocol ID
- NCC4005
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Cancer Foundation Beijing Hope Marathon Fund
- ClinicalTrials.gov ID
- NCT06509022
- Acronym / sponsor ID
- NCC4005
- Conditions
- GASTROINTESTINAL NEOPLASMS
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- 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.
The goal of this observational study intends to explore the evolution trend and related factors of postoperative reflux of esophageal cancer based on PEPTEST detection, in order to identify postoperative reflux
The main question it aims to answer are:
to provide evidence for high-risk groups, improvement of surgical methods for esophageal cancer, and development of health education programs to prevent postoperative reflux.
Using convenient sampling method, patients undergoing esophagectomy in thoracic surgery Department of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 were continuously enrolled. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery.
The incidence of pathological reflux at 5 time points before and after surgery was observed and compared (that is, both T-line and C-line were shown). The trend of pepsin content in saliva before and after operation; The relationship between pathological reflux and surgical factors; The relationship between pathological reflux and life habits after operation; Relationship between pathological regurgitation and demographic characteristics.
Detailed description
The subjects of this study were selected from the patients who underwent esophagectomy in the Department of Thoracic Surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 to December 1, 2023, and the patients who underwent esophagectomy in the Department of thoracic surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. To describe the evolution trend of postoperative reflux in patients with esophageal cancer can be used for anticipatory sexual health education. To explore the relevant factors of reflux: to identify the inherent factors, such as gender, BMI, etc., to give preventive intervention to high-risk groups; The variable factors such as the length and width of the tube stomach can be improved.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Before surgery | – | Diagnostic Test: PEPTEST testA patient with esophageal cancer before surgery |
| Before discharge | – | Diagnostic Test: PEPTEST testPatients with esophageal cancer who were not discharged after surgery |
| 1 month after surgery | – | Diagnostic Test: PEPTEST testOne month after surgery for esophageal cancer |
| 3 months after surgery | – | Diagnostic Test: PEPTEST testThree months after surgery for esophageal cancer |
| 6 months after surgery | – | Diagnostic Test: PEPTEST testSix months after surgery for esophageal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent resection for esophageal cancer were continuously enrolled.
Key inclusion criteria (3 listed)
- Patients who were pathologically diagnosed with esophageal cancer and underwent esophagectomy for esophageal cancer.
- The patient can communicate in Mandarin.
- Those who can come to the hospital for review on time.
Key exclusion criteria (3 listed)
- People with cognitive impairment or mental illness.
- Complicating other serious life-threatening diseases (such as leukemia or autoimmune diseases).
- Unwilling to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEPTEST testQuantitative determination of gastric salivary amylase。 | Diagnostic test | 1 month after surgery, 3 months after surgery, 6 months after surgery, Before discharge, Before surgery |
Primary outcome
Incidence of pathological regurgitation
Time frame: 2023.1.1-2023.12.1
Incidence of pathological regurgitation at 5 time points before and after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GASTROINTESTINAL NEOPLASMS, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of pathological regurgitation (time frame: 2023.1.1-2023.12.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.