Non-small Cell Lung Cancer Clinical Trial
— TRCRLCOfficial title:
Correlation Study of Blood and Tissue Thioredoxin Reductase Activity in Early Stage On-small Cell Lung Cancers
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Hunan Provincal Tumor Hospital | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Hunan Province Tumor Hospital |
China,
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 |
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