Clinical trial NCT01985113: Correlation Research of Thioredoxin Reductase in Lung Cancer
Official title: Correlation Study of Blood and Tissue Thioredoxin Reductase Activity in Early Stage On-small Cell Lung Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Benign Neoplasm of Lung
Keywords: thioredoxin reductase
non-small cell lung cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with early staged NSCLC and lung benign lesion Patients show resectable lung mass in CT scan, suspected lung cancer and receive surgery in Affiliated Cancer Hospital of Xiangya School of Medicine Central South University

Brief summary: In pre-clinical study the investigators found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.

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 using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early staged(Ⅰ\~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. The secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven staged(Ⅰ\~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass
* Receive surgery in Thoracic Oncology department Hunan Tumor Hospital without contraindication of surgery
* Malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
* Signed informed consent about providing blood and tissue for study

Exclusion Criteria:

* Patients have received antitumor treatment
* 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, tumor and pericarcinomatous tissue
timeFrame: blood should be taken in 2 days before surgery, tumor and pericarcinomatous tissues should be stored and tested in one month
Secondary outcomes:
measure: Measure the difference of thioredoxin reductase activity between lung cancer tissue and lung benign mass
timeFrame: Tumor tissue or lung benign mass obtained during surgery should be stored at -180 degree within 5 mins and enzyme activity should be measured within one month
measure: Measure the thioredoxin reductase mRNA and protein expression in tumor and pericarcimomatous tissue
timeFrame: Tumor tissue or pericarcimomatous tissue should be stored at -180 degree, then qRT-PCR should be done within 3 months
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: