Correlation Research of Thioredoxin Reductase in Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— TRCRLC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985113
• Other study ID #: TR001
• Secondary ID: TRRFLC1
• Status: Completed
• Phase: N/A
• First received: November 4, 2013
• Last updated: February 14, 2016
• Start date: May 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pathologically proven staged(?~?A) 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Neoplasm of Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes