Esophageal CancerNCT06722300
Clinical Study on the Impact of Eradication of Oral Porphyromonas Gingivalis on the Prognosis of Early Esophageal Cancer After ESD Surgery
A study testing Ultrasonic teeth cleaning plus Tinidazole microneedle patches applying in people with Esophageal Cancer, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial summary
Porphyromonas gingivalis (Pg) is a representative pathogenic bacterium of periodontitis and is a Gram-negative anaerobic bacterium. Epidemiological studies suggest that periodontitis is positively correlated with the risk of gastrointestinal tumors such as esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Ultrasonic teeth cleaning plus Tinidazole microneedle patches applying
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 856 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2029
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed esophageal cancer;
- Newly diagnosed patients who meet the absolute and relative indications for ESD;
- ECOG: 0～1;
- Expected survival ≥12 weeks;
- Receive ESD treatment within 28 days and meet R0 standards;
- The main organ functions are normal, that is, the following standards are met:
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- Routine blood examination:
- a.HB≥90g/L; b.ANC≥1.5×10^9/L; c.PLT ≥80×10^9/L;
- Biochemical examination:
- ALB≥30g/L; b.ALT and AST≤2.5ULN; if there is liver metastasis, ALT and AST≤5ULN; c.TBIL≤1.5ULN;
- Women of childbearing potential must agree to use contraceptive measures (such as intrauterine devices, birth control pills or condoms) during the study and within 6 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment , and must be non-lactating patients; males should agree that they must use contraceptive measures during the study period and within 6 months after the end of the study period;
- The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- Does not meet the above selection criteria;
- Patients with distant visceral metastasis;
- Pathological confirmation after ESD does not meet Tis, T1a, R0 or the depth of the lesion exceeds pSM1, and the depth of submucosal invasion is >200 μm;
- The lesions are ulcerated and poorly differentiated (poorly differentiated, undifferentiated);
- There is lymphovascular infiltration;
- Those who are allergic to tinidazole or have metabolic disorders;
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- Patients who require warfarin anticoagulation and those who cannot quit drinking;
- Patients who cannot tolerate ultrasonic tooth cleaning;
- Pregnant or lactating women;
- Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Those who have a history of psychotropic drug abuse and are unable to quit or patients with mental disorders;
- Patients who have participated in other drug clinical trials within four weeks;
- Patients who, according to the researcher's judgment, have concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study;
- Patients with recurrent oral ulcers or other oral diseases that affect oral flora;
- Patients with chronic infectious diseases or autoimmune diseases who require long-term or repeated application of antibacterial drugs or glucocorticoids; those deemed not suitable for inclusion by the researcher.
- The researcher believes that the applicant is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
About this study
Porphyromonas gingivalis (Pg) is a representative pathogenic bacterium of periodontitis and is a Gram-negative anaerobic bacterium. Epidemiological studies suggest that periodontitis is positively correlated with the risk of gastrointestinal tumors such as esophageal cancer. Pg has been extensively studied due to its unique ability to invade epithelial cells and survive in host blood and tissues, and has been confirmed to be associated with esophageal cancer, pancreatic cancer, and oral cancer. Pg is enriched in esophageal cancer tissues and atypical hyperplasia lesions of esophageal mucosa, and is rarely found in corresponding non-tumor parts, cardiac cardia, and stomach. Treating normal esophageal mucosal epithelial cells with Pg medium can induce atypical hyperplasia. Chen et al found that the Pg infection rate in esophageal squamous cell carcinoma is as high as 57%. Gao S et al. used 16S rDNA PCR technology to detect 100 ESCC patients. The detection rate of Pg pan-antigen was 61% in tumor tissues, 12% in para-cancerous tissues, and was not detected in normal mucosal tissues. Studies have shown that Pg and Pg/Prevotella ratio in saliva can be used as reference indicators for the diagnosis of esophageal cancer. The abundance of Pg in saliva and dental plaque is associated with the development of esophageal squamous cell carcinoma and poor prognosis. High levels of Pg-specific antibodies in serum are an independent predictor of poor prognosis in esophageal squamous cell carcinoma. Gao et al.'s study found that Pg infection is closely related to local recurrence after endoscopic resection. Studies based on ESCC patients data, animal models and esophageal squamous cell carcinoma cell lines have confirmed that Pg promotes the occurrence and development of esophageal cancer, leads to resistance to neoadjuvant chemotherapy, and weakens the efficacy of anti-tumor treatment. In summary, whether the recurrence of early esophageal cancer after ESD can be controlled by removing Pg deserves further exploration.
To this end, based on the combined treatment of mechanical removal and antibacterial drugs, this study designed a method that combines ultrasonic tooth cleaning with tinidazole oral composite microneedle patches to completely remove oral Pg and evaluate the impact on the prognosis of early ESCC after ESD therapy by extra removal of oral Porphyromonas gingivalis.
Read the detailed description
The new oral microneedle patch was developed by the Oncology Molecular Biology Laboratory of the First Affiliated Hospital of Henan University of Science and Technology. The patch consists of a dissolvable basement membrane part and a needle tip loaded with drugs and polylactic acid-co-glycolic acid microspheres. The base film of the new oral microneedle patch is made of 10% gelatin. 10% gelatin can solidify at room temperature and dissolve in a few minutes at body temperature. Antibiotics can be loaded directly into the gelatin-based membrane and released rapidly. The tip part is made of gelatin methacryloyl (GelMA) cross-linked by UV light. GelMA forms a hydrogel structure that gradually degrades and can be used as a carrier for sustained drug release. After applying the oral microneedle patch, the basement membrane quickly dissolves and releases the tinide file, which can effectively reduce the content of harmful bacteria in the oral cavity. The needle tip structure composed of GelMA can penetrate and stay in the gingival tissue, continuously releasing tinide files and cytokines to promote the repair of gingival tissue.
- Conditions
- Esophageal Cancer
- Being tested
- Ultrasonic teeth cleaning plus Tinidazole microneedle patches applying
- Keywords
- Esophageal Cancer；, ESD, Porphyromonas gingivalis
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic teeth cleaning plus Tinidazole microneedle patches applyingDevice
After gargling with compound chlorhexidine rinse or 3% hydrogen peroxide rinse for 1 minute, ultrasonic teeth cleaning was performed. After teeth cleaning, the wound was rinsed with 3% hydrogen peroxide and bleeding was stopped. After ultrasonic teeth cleaning, two metronidazole oral composite microneedle patches were immediately applied to the upper and lower gums near the inner side of the first molar, especially where the teeth were lost or damaged. The mouth was kept closed for 15 minutes. After the microneedles were fully degraded, the patient could leave the clinic.
| Study group | Role | What they receive |
|---|---|---|
| No.1 | No intervention | Pg negative |
| No.2 | Experimental | Patients with Pg infection Receives: Device: Ultrasonic teeth cleaning plus Tinidazole microneedle patches applying |
| No.3 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival (RFS)
From enrollment to the end of follow-up or the date of first documented progression
Measured: up to 5 years
Secondary outcomes (2)
overall survival (OS)
From randomization to the end of follow-up or the time of the death event
Measured: up to 5 years
the safety of the intervention methods
From enrollment to the end of follow-up or the date of confirmed adverse event
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Shegan Gao, MD，pHD, Principal investigator, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722300
- Sponsor's protocol ID
- PGESCC002
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will decide whether to share based on the research data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Impact of Eradication of Oral Porphyromonas Gingivalis on the Prognosis of Early Esophageal Cancer After ESD Surgery
- ClinicalTrials.gov ID
- NCT06722300
- Acronym / sponsor ID
- PGESCC002
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer；, ESD, Porphyromonas gingivalis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Dec 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.
Porphyromonas gingivalis (Pg) is a representative pathogenic bacterium of periodontitis and is a Gram-negative anaerobic bacterium. Epidemiological studies suggest that periodontitis is positively correlated with the risk of gastrointestinal tumors such as esophageal cancer. Pg has been extensively studied due to its unique ability to invade epithelial cells and survive in host blood and tissues, and has been confirmed to be associated with esophageal cancer, pancreatic cancer, and oral cancer. Pg is enriched in esophageal cancer tissues and atypical hyperplasia lesions of esophageal mucosa, and is rarely found in corresponding non-tumor parts, cardiac cardia, and stomach. Treating normal esophageal mucosal epithelial cells with Pg medium can induce atypical hyperplasia. Chen et al found that the Pg infection rate in esophageal squamous cell carcinoma is as high as 57%. Gao S et al. used 16S rDNA PCR technology to detect 100 ESCC patients. The detection rate of Pg pan-antigen was 61% in tumor tissues, 12% in para-cancerous tissues, and was not detected in normal mucosal tissues. Studies have shown that Pg and Pg/Prevotella ratio in saliva can be used as reference indicators for the diagnosis of esophageal cancer. The abundance of Pg in saliva and dental plaque is associated with the development of esophageal squamous cell carcinoma and poor prognosis. High levels of Pg-specific antibodies in serum are an independent predictor of poor prognosis in esophageal squamous cell carcinoma. Gao et al.'s study found that Pg infection is closely related to local recurrence after endoscopic resection. Studies based on ESCC patients data, animal models and esophageal squamous cell carcinoma cell lines have confirmed that Pg promotes the occurrence and development of esophageal cancer, leads to resistance to neoadjuvant chemotherapy, and weakens the efficacy of anti-tumor treatment. In summary, whether the recurrence of early esophageal cancer after ESD can be controlled by removing Pg deserves further exploration.
To this end, based on the combined treatment of mechanical removal and antibacterial drugs, this study designed a method that combines ultrasonic tooth cleaning with tinidazole oral composite microneedle patches to completely remove oral Pg and evaluate the impact on the prognosis of early ESCC after ESD therapy by extra removal of oral Porphyromonas gingivalis.
Detailed description
The new oral microneedle patch was developed by the Oncology Molecular Biology Laboratory of the First Affiliated Hospital of Henan University of Science and Technology. The patch consists of a dissolvable basement membrane part and a needle tip loaded with drugs and polylactic acid-co-glycolic acid microspheres. The base film of the new oral microneedle patch is made of 10% gelatin. 10% gelatin can solidify at room temperature and dissolve in a few minutes at body temperature. Antibiotics can be loaded directly into the gelatin-based membrane and released rapidly. The tip part is made of gelatin methacryloyl (GelMA) cross-linked by UV light. GelMA forms a hydrogel structure that gradually degrades and can be used as a carrier for sustained drug release. After applying the oral microneedle patch, the basement membrane quickly dissolves and releases the tinide file, which can effectively reduce the content of harmful bacteria in the oral cavity. The needle tip structure composed of GelMA can penetrate and stay in the gingival tissue, continuously releasing tinide files and cytokines to promote the repair of gingival tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No.1 | No intervention | –Pg negative |
| No.2 | Experimental | Device: Ultrasonic teeth cleaning plus Tinidazole microneedle patches applyingPatients with Pg infection |
| No.3 | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed esophageal cancer;
- Newly diagnosed patients who meet the absolute and relative indications for ESD;
- ECOG: 0～1;
- Expected survival ≥12 weeks;
- Receive ESD treatment within 28 days and meet R0 standards;
Key exclusion criteria (16 listed)
- Does not meet the above selection criteria;
- Patients with distant visceral metastasis;
- Pathological confirmation after ESD does not meet Tis, T1a, R0 or the depth of the lesion exceeds pSM1, and the depth of submucosal invasion is >200 μm;
- The lesions are ulcerated and poorly differentiated (poorly differentiated, undifferentiated);
- There is lymphovascular infiltration;
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 |
|---|---|---|
| Ultrasonic teeth cleaning plus Tinidazole microneedle patches applyingAfter gargling with compound chlorhexidine rinse or 3% hydrogen peroxide rinse for 1 minute, ultrasonic teeth cleaning was performed. After teeth cleaning, the wound was rinsed with 3% hydrogen peroxide and bleeding was stopped. After ultrasonic teeth cleaning, two metronidazole oral composite microneedle patches were immediately applied to the upper and lower gums near the inner side of the first molar, especially where the teeth were lost or damaged. The mouth was kept closed for 15 minutes. After the microneedles were fully degraded, the patient could leave the clinic. | Device | No.2 |
Primary outcome
recurrence-free survival (RFS)
Time frame: up to 5 years
From enrollment to the end of follow-up or the date of first documented progression
2 secondary outcomes
overall survival (OS)
Time frame: up to 5 years
the safety of the intervention methods
Time frame: up to 5 years
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 9 Dec 2024.
- Individual participant dataSharing planned: Undecided. The researchers will decide whether to share based on the research data.
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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.
Shegan Gao, MD，pHD principal investigator
The First Affiliated Hospital of Henan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic teeth cleaning plus Tinidazole microneedle patches applying in people with Esophageal Cancer, run by The First Affiliated Hospital of Henan University of Science and Technology 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 12 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 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?
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?
recurrence-free survival (RFS) (time frame: up to 5 years). 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 9 Dec 2024.