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RecruitingNCT06190847Updated Jan 5, 2024

Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer

An observational study in Esophageal Squamous Cell Carcinoma, Chemoradiotherapy and Initial Inoperable, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Anhui Provincial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
97
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Esophageal cancer accounts for more than half of the world, seriously affecting people's health in China. 95% patients are squamous cell carcinoma. Surgery is the preferred treatment for early and middle stage esophageal cancer, but patients with clinical stage T4b or other surgical contraindications have no surgical opportunity. In recent years, radical chemoradiotherapy has played a key role in the treatment of local advanced esophageal cancer with some poor predicting biomarkers. Oral bacteria may play a pathogenic role in cancer and other chronic diseases by producing chemical carcinogens and inflammatory factors through direct metabolism. A large number of studies have also suggested that tooth loss and poor oral hygiene are closely related to upper digestive tract cancer, indicating the possible role of oral microorganisms in the occurrence and development of upper digestive tract cancer, and saliva is the main source of oral flora colonization. Therefore, it is worth further research to explore the interaction between microbial metabolism imbalance and radiotherapy in patients with esophageal cancer. In summary, we intend to conduct a prospective cohort study to explore the role of salivary microbes in radiotherapy in patients with initially inoperable patients with local advanced esophageal cancer.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
  • Chemoradiotherapy
  • Initial Inoperable
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

initial inoperable esophageal squamous cell carcinoma

Inclusion criteria

  • 18-85 years old;

    • Eastern Cooperative Oncology Group (ECOG) 0-2;
    • Esophageal squamous cell carcinoma;
    • cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
    • initial unresectable at initial diagnosis confirmed by thoracic surgeons;
    • Treatment naive;
    • No contraindications for adjuvant chemoradiotherapy;
    • Signature of inform consent.

Exclusion criteria

Exclusion Criteria:

    • younger than 18 years old or older than 85 years old;

      • ECOG>2;
      • Esophageal adenocarcinoma, small-cell cancer and other pathological types;
      • cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
      • Resectable at initial diagnosis confirmed by thoracic surgeons;
      • Previous treatment of chemotherapy, radiotherapy, and other treatment;
      • Contraindications for chemoradiotherapy;
      • No signature of inform consent.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
97 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • Experimental

    cancer

    Other: regular chemoradiotherapy

Interventions

  • Otherregular chemoradiotherapy

    regular chemoradiotherapy

05

What researchers measure

Primary outcomes

  1. pCR

    Time frame: 1 month post treatment

Secondary outcomes

  1. EFS

    Time frame: 1 to 3 years

  2. the surgical conversion rate

    Time frame: 1month post treatment

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06190847
Lead sponsor
Anhui Provincial Hospital
Responsible party
Dong Qian (dr, Anhui Provincial Hospital) — Principal investigator
First posted
Jan 5, 2024
Start date
Jul 1, 2023
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jan 5, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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