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NCT04522687Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2020 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
19 Aug 2020
Start date
Jan 2012
Primary completion date
Dec 2023
Lead sponsor
Shanghai Cancer Hospital, China
NCT number
NCT04522687

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From Jan 2012 to the primary completion date, Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
  • Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.

Who the study is looking for

  • 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:
  • 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;
  • 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;
  • Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.