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

Non-small Cell Lung Cancer Stage I Clinical Trial

Official title:

Early Warning Study of Plasma Thioredoxin Reductase Activity in Non-small Cell Lung Cancers Received Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991418
• Other study ID #: TR002
• Secondary ID: EWSOTRILC
• 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, 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

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.

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, 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage I
• Non-small Cell Lung Cancer Stage II
• Non-small Cell Lung Cancer Stage IIIA

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	Measure the thioredoxin reductase activity in blood at the setting time point, before surgery, 3-5 days after surgery, after every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage ?A and low risk ?B. Blood will be taken before surgery, 3-5 days after surgery, before adjuvant chemotherapy, after two cycles of adjuvant chemotherapy, after every 3 months after adjuvant chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage high risk ?B IIA IIB and IIIA.	blood should be taken before and 3-5 days after surgery, then every 3 months till 2 years, then every 6 month till 3 years	Yes
Secondary	Measure carcina embryonic antigen(CEA) level in blood	Measure the carcina embryonic antigen(CEA) level in blood at the setting time point, before surgery, 3-5 days after surgery, after every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage ?A and low risk ?B. Blood will be taken before surgery, 3-5 days after surgery, before adjuvant chemotherapy, after two cycles of adjuvant chemotherapy, after every 3 months after adjuvant chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage high risk ?B IIA IIB and IIIA.	blood should be taken before and 3-5 days after surgery, then every 3 months till 2 years, then every 6 month till 3 years	Yes