Clinical trial NCT01980212: Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer
Official title: Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Non-small Cell Lung Cancer
First Line Treatment
Thioredoxin Reductase Activity
Carcinoembryonic Antigen
Progression
Keywords: non-small cell lung cancer
thioredoxin reductase
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-small lung cancer and receiving platinum based first-line chemotherapy in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University/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.

Eligibility criteria: 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

Primary outcomes:
measure: To measure the thioredoxin reductase activity in blood
timeFrame: may 2013 - may 2014 (1 year)
Secondary outcomes:
measure: To measure the carcinoembryonic antigen (CEA) level in blood
timeFrame: may 2013- may 2014 (1 year)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Nong Yang, MD
role: STUDY_CHAIR
References: