Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT06190847

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

Led by Anhui Provincial Hospital · Updated on 2024-01-05

97

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Diagnosis of esophageal squamous cell carcinoma
  • Clinical stage cT2-4aN0-3M0 confirmed by radiological examination (AJCC 8th edition)
  • Tumor is initially unresectable confirmed by thoracic surgeons
  • No prior cancer treatment (treatment naive)
  • No contraindications for adjuvant chemoradiotherapy
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 85 years
  • ECOG performance status greater than 2
  • Diagnosis of esophageal adenocarcinoma, small-cell cancer, or other pathological types
  • Clinical stage cT1anyNM0, cT4banyNM0, or any other cTanyNM0 confirmed by radiological examination
  • Tumor resectable at initial diagnosis confirmed by thoracic surgeons
  • Previous chemotherapy, radiotherapy, or other cancer treatments
  • Contraindications for chemoradiotherapy
  • No signed informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dong Qian

Hefei, Anhui, China, 230001

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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