Actively Recruiting

Age: 18Years +
All Genders
ID04522687

Observation of the Impact of Radiotherapy With or Without Chemotherapy on Peripheral Blood Lymphocyte Subsets in Thoracic Cancer Patients

Led by Shanghai Cancer Hospital, China · Updated on 2020-08-21

500

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are observing changes and the prognostic significance of peripheral blood lymphocyte subsets in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma, and thymic epithelial carcinoma. These patients have undergone radiotherapy with or without chemotherapy. The study aims to understand how these treatments may affect the immune cells in the blood and their relationship with patient outcomes. This observational study does not involve assigning treatments but follows patients who receive radiotherapy alone or combined with chemotherapy as part of their care. Researchers will collect and analyze blood samples to monitor lymphocyte subsets before and during treatment. The study is conducted at a single center and includes patients with confirmed thoracic cancers who meet specific clinical and laboratory criteria. Participants will be followed for up to five years to evaluate overall survival and progression-free survival as primary and secondary outcomes. The study involves collecting tumor biopsies before and during treatment, tracking organ function and blood counts, and monitoring patient health status. Data collected will help assess the value of peripheral blood lymphocytes as prognostic markers in thoracic cancer treatment.

CONDITIONS

Brief Title

Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years
  • ECOG performance status 0-1
  • Pathologically confirmed diagnosis of NSCLC, esophageal squamous cell carcinoma, or thymic epithelial tumor
  • Life expectancy greater than 3 months
  • No indication for palliative radiotherapy as judged by the investigator
  • Prior surgery allowed if recovered from surgery-related toxicity or complications
  • Signed informed consent for collection of fresh tumor biopsies before and during treatment
  • Agreement to use effective contraception during the trial for women of childbearing age and men
  • Adequate organ function within 1 week prior to enrollment, including bone marrow, liver, and kidney function
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • History of any other malignancy
  • Indication for palliative radiotherapy as judged by the investigator
  • Active infection
  • Congestive heart failure, recent myocardial infarction (within 6 months), unstable angina, or cardiac arrhythmia
  • Previous tumor vaccine treatment or live attenuated vaccine within 4 weeks before treatment start
  • Mental disorders, drug abuse, or social conditions that may impair compliance as judged by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 5 years

Participants who undergo routine care are observed to assess the impact of radiotherapy with or without chemotherapy on peripheral blood lymphocyte subsets.

Periodic visits as per routine care

Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

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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

0

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