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

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

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Key information

Conditions

Non-small Cell Lung Cancer Stage I Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIA Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Measure the thioredoxin reductase activity in blood

Time frame: 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

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 ⅠA and low risk ⅠB. 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 ⅠB IIA IIB and IIIA.

Secondary outcomes

Measure carcina embryonic antigen(CEA) level in blood

Time frame: 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

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 ⅠA and low risk ⅠB. 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 ⅠB IIA IIB and IIIA.

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Nov 25, 2013
Registry last updated: Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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