NCT04522687 Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer
| NCT ID | NCT04522687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Cancer Hospital, China |
| Condition | NSCLC |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2012-01-01 |
| Primary Completion | 2023-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2012-01-01 with a primary completion date of 2023-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.
Eligibility Criteria
Inclusion Criteria: Age at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor. Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator. Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery. Signed informed consent for the use of fresh tumor biopsies before and during the treatment. Women of childbearing age and men must agree to use effective contraception during the trial. Adequate organ function within 1 week prior to the enrollment： 1. Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L; 2. Adequate hepatic function: total bilirubin \< 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN; 3. Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min; Exclusion Criteria: Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator. Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia. Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment. Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
Frequently Asked Questions
Who can join the NCT04522687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04522687 currently recruiting?
Yes, NCT04522687 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Cancer Hospital, China to inquire about joining.
Where is the NCT04522687 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04522687 clinical trial?
NCT04522687 is sponsored by Shanghai Cancer Hospital, China. The trial plans to enroll 500 participants.