Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)

NCT ID: NCT01991418

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-02-29

Brief Summary

In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin reductase may be a warning markers in excised non-small lung cancers, serum activity of this enzyme may elevated before CT scan

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 in blood in staged(Ⅰ~ⅢA) non-small lung cancers, to study the warning relapse ability of thioredoxin reductase in blood. The secondary objective is to compare the warning relapse activity of blood thioredoxin reductase activity with carcinoembryonic antigen (CEA) in subjects who received surgery. Blood will be collected in subjects before surgery, 5 days after surgery, and every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse for the subjects at stage ⅠA and low risk ⅠB. Blood will be collected before surgery, 5 days after surgery, before adjuvant chemotherapy, after 2 circles of all adjuvant chemotherapy, then every 3 months after adjuvant chemotherapy till 2 years, and every 6 months till 3 years, or collect blood till tumor relapse for the subjects of high risk ⅠB~ⅢA, evaluation CT results every time collect blood samples.

Conditions

Non-small Cell Lung Cancer Stage I; Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage IIIA

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

early staged non-small cell lung cancer

patients diagnosed as early staged non-small cell lung cancer and received surgery in HunanPTH

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Pathologically proven staged(Ⅰ~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass, fast pathology proved non-small cell lung cancer
• Receive surgery in Thoracic Oncology department Affiliated Cancer Hospital of xiangya School of Medicine Central South University without contraindication of surgery
• Tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
• Signed informed consent to provide blood and tissue for study

Exclusion Criteria

• Patients received antitumor treatment before
• Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
• Pregnant or breast feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nong Yang

chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nong Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Province Tumor Hospital

Locations

Hunan Provincal Tumor Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

EWSOTRILC

Identifier Type: OTHER

Identifier Source: secondary_id

TR002

Identifier Type: -

Identifier Source: org_study_id