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Clinical Trials/NCT01985113
NCT01985113CompletedNot Applicable

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

Hunan Province Tumor Hospital1 site in 1 country165 target enrollmentStarted: May 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
165
Locations
1
Primary Endpoint
measure the thioredoxin reductase activity in blood, tumor and pericarcinomatous tissue

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

measure the thioredoxin reductase activity in blood, tumor and pericarcinomatous tissue

Time Frame: blood should be taken in 2 days before surgery, tumor and pericarcinomatous tissues should be stored and tested in one month

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

Secondary Outcomes

  • 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)
  • 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)

Investigators

Sponsor
Hunan Province Tumor Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nong Yang

chief

Hunan Province Tumor Hospital

Study Sites (1)

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