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

Completed

• Conditions: Advanced Non-small Cell Lung Cancer; First Line Treatment; Thioredoxin Reductase Activity; Carcinoembryonic Antigen; Progression

• Registration Number: NCT01980212
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-05-01
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-08
• Primary Completion: 2016-12-01
• Study Completion: 2018-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the thioredoxin reductase activity in blood	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 Outcome Measures

Name	Time	Method
To measure the carcinoembryonic antigen (CEA) level in blood	may 2013- may 2014 (1 year)	Measure the CEA level every time compared with thioredoxin reductase activity

Trial Locations

Locations (1)

Hunan Provincal Tumor Hospital; 🇨🇳 Changsha, Hunan, China