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

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980212
• Other study ID #: TRSTILC
• Status: Completed
• Start date: May 1, 2013
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2020
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pathologically proven non-small cell lung cancer, stage ? patients or unsuitable for local treatment of ?B 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 ?B or ?)

• 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

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoembryonic Antigen
• Carcinoma, Non-Small-Cell Lung
• First Line Treatment
• Lung Neoplasms
• Progression
• Thioredoxin Reductase Activity

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