Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer

In pre-clinical study we 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, and after any kind of treatment serum thioredoxin reductase activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity could be a warning marker for early progression of first-line treatment for advanced non-small cell lung cancer

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Key information

Conditions

Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoembryonic Antigen Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Disease Attributes Disease Progression First Line Treatment Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Progression Respiratory Tract Diseases Respiratory Tract Neoplasms Thioredoxin Reductase Activity 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 involving patients in 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 in subjects received platinum based chemotherapy, to study the warning progression ability of thioredoxin reductase in blood. The secondary objective is to compare the warning progression activity of blood thioredoxin reductase reductase activity with carcinoembryonic antigen in subjects received platinum based first-line chemotherapy. Blood will be collected before chemotherapy, after every 2 cycles of chemotherapy, every 3 months after all first-line chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor progression, evaluation CT results every time collecting blood samples.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Pathologically proven non-small cell lung cancer, stage Ⅳ patients or unsuitable for local treatment of ⅢB stage patients
Malignant tumor treatment naive including surgery（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before, except for lung cancer patients who received surgery and adjuvant chemotherapy after 12 month then diagnosed with stage ⅢB or Ⅳ）
Signed informed consent would like to provide blood for research

Exclusion criteria

Patients received antitumor treatment before
Patients with contraindication of chemotherapy
Pregnant or breast feeding women

Treatment and study plan

Primary outcomes

To measure the thioredoxin reductase activity in blood

Time frame: may 2013 - may 2014 (1 year)

3-4 ml whole blood was obtained and then centrifuged and stored at -20 ℃, thioredoxin reductase activity was measured within 30 days using 5，5'-Dithio bis-（2-nitrobenzoic acid）(DTNB) method.

Secondary outcomes

To measure the carcinoembryonic antigen (CEA) level in blood

Time frame: may 2013- may 2014 (1 year)

Measure the CEA level every time compared with thioredoxin reductase activity

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2018
First posted: Nov 8, 2013
Registry last updated: Mar 26, 2020

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.

Published trials that share one or more normalized conditions with this study.

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