Correlation Research of Thioredoxin Reductase in Lung Cancer (TRCRLC)

Correlation Study of Blood and Tissue Thioredoxin Reductase Activity in Early Stage On-small Cell Lung Cancers

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Benign Neoplasm of Lung

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.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Provincal Tumor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
early staged non-small cell lung cancers; patients who diagnosed as early staged non-small cell lung cancer after surgery
lung benign mass patients; patients who diagnosed as lung benign mass after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure the thioredoxin reductase activity in blood, tumor and pericarcinomatous tissue	3-4 ml blood should be taken and centrifuged in 30 mins, then the serum should be stored at -20 degree, then serum thioredoxin reductase activity should be measured in one month. Tumor and pericarcinomatous tissues should be stored at -180 degree and enzyme activity should be measured within one month	blood should be taken in 2 days before surgery, tumor and pericarcinomatous tissues should be stored and tested in one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the difference of thioredoxin reductase activity between lung cancer tissue and lung benign mass	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.	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 the thioredoxin reductase mRNA and protein expression in tumor and pericarcimomatous tissue	Tumor tissue or pericarcimomatous tissue should be stored at -180 degree, then qRT-PCR should be done within 3 months	Tumor tissue or pericarcimomatous tissue should be stored at -180 degree, then qRT-PCR should be done within 3 months

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (ESTIMATE): November 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; thioredoxin reductase
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TR001; TRRFLC1 (OTHER: HunanPTH)