Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)

N/ACompletedNCT01991418

Hunan Province Tumor Hospital165 enrolled

Overview

In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin reductase may be a warning markers in excised non-small lung cancers, serum activity of this enzyme may elevated before CT scan

This is a cooperative research project in Thoracic Surgery Department and Medical Oncology department of Affiliated Cancer Hospital of xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity in blood in staged(Ⅰ\~ⅢA) non-small lung cancers, to study the warning relapse ability of thioredoxin reductase in blood. The secondary objective is to compare the warning relapse activity of blood thioredoxin reductase activity with carcinoembryonic antigen (CEA) in subjects who received surgery. Blood will be collected in subjects before surgery, 5 days after surgery, and every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse for the subjects at stage ⅠA and low risk ⅠB. Blood will be collected before surgery, 5 days after surgery, before adjuvant chemotherapy, after 2 circles of all adjuvant chemotherapy, then every 3 months after adjuvant chemotherapy till 2 years, and every 6 months till 3 years, or collect blood till tumor relapse for the subjects of high risk ⅠB\~ⅢA, evaluation CT results every time collect blood samples.

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Non-small Cell Lung Cancer Stage I Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically proven staged(Ⅰ\~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass, fast pathology proved non-small cell lung cancer * Receive surgery in Thoracic Oncology department Affiliated Cancer Hospital of xiangya School of Medicine Central South University without contraindication of surgery * Tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before） * Signed informed consent to provide blood and tissue for study Exclusion Criteria: * Patients received antitumor treatment before * Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy * Pregnant or breast feeding women

Locations (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, China

Outcomes

Primary Outcomes

Measure the thioredoxin reductase activity in blood

Measure the thioredoxin reductase activity in blood at the setting time point, before surgery, 3-5 days after surgery, after every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage ⅠA and low risk ⅠB. Blood will be taken before surgery, 3-5 days after surgery, before adjuvant chemotherapy, after two cycles of adjuvant chemotherapy, after every 3 months after adjuvant chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage high risk ⅠB IIA IIB and IIIA.

Time frame: blood should be taken before and 3-5 days after surgery, then every 3 months till 2 years, then every 6 month till 3 years

Secondary Outcomes

Measure carcina embryonic antigen(CEA) level in blood

Measure the carcina embryonic antigen(CEA) level in blood at the setting time point, before surgery, 3-5 days after surgery, after every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage ⅠA and low risk ⅠB. Blood will be taken before surgery, 3-5 days after surgery, before adjuvant chemotherapy, after two cycles of adjuvant chemotherapy, after every 3 months after adjuvant chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage high risk ⅠB IIA IIB and IIIA.

Time frame: blood should be taken before and 3-5 days after surgery, then every 3 months till 2 years, then every 6 month till 3 years

Data from ClinicalTrials.gov

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