Clinical trial NCT01991418: Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)
Official title: Early Warning Study of Plasma Thioredoxin Reductase Activity in Non-small Cell Lung Cancers Received Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer Stage I
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA
Keywords: non-small cell lung cancer
thioredoxin reductase
carcina embryonic antigen
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with resectable non-small lung cancer and received surgery in Affiliated Cancer Hospital of xiangya School of Medicine Central South University, HunanPTH

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the thioredoxin reductase activity in blood
timeFrame: 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: Measure carcina embryonic antigen(CEA) level in blood
timeFrame: 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
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Nong Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: