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

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ClinicalTrials.gov Identifier: NCT01980212
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Advanced Non-small Cell Lung Cancer First Line Treatment Thioredoxin Reductase Activity Carcinoembryonic Antigen Progression

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 Design

Study Type : Observational
Estimated Enrollment : 150 participants
Time Perspective: Prospective
Official Title: Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer
Study Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
first line advanced non-small cell lung cancer
patients newly diagnosed advanced non-small cell lung cancer, and received platinum based chemotherapy in Hunan Province Tumor Hospital


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
3-4 ml whole blood was obtained and then centrifuged and stored at -20 ℃

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980212


Contacts
Contact: Nong Yang, MD +86 731 89762323 yangnong0217@163.com
Contact: Ming Zhou, MD +86 731 89762320 zhouming243@163.com

Locations
China, Hunan
Hunan Provincal Tumor Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Nong Yang, MD    +86 731 89762323    yangnong0217@163.com   
Contact: Chunhua Zhou, MD    +86 731 89762321    zhouchunhua@hnszlyy.com   
Principal Investigator: Nong Yang, MD         
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
Study Chair: Nong Yang, MD Hunan Province Tumor Hospital
More Information

Responsible Party: Nong Yang, chief, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT01980212     History of Changes
Other Study ID Numbers: TRSTILC
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Nong Yang, Hunan Province Tumor Hospital:
non-small cell lung cancer
thioredoxin reductase

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms