We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991418
First Posted: November 25, 2013
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nong Yang, Hunan Province Tumor Hospital
  Purpose
In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin reductase may be a warning markers in excised non-small lung cancers, serum activity of this enzyme may elevated before CT scan

Condition
Non-small Cell Lung Cancer Stage I Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage IIIA

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Early Warning Study of Plasma Thioredoxin Reductase Activity in Non-small Cell Lung Cancers Received Surgery

Resource links provided by NLM:


Further study details as provided by Nong Yang, Hunan Province Tumor Hospital:

Primary Outcome Measures:
  • Measure the thioredoxin reductase activity in blood [ Time Frame: blood should be taken before and 3-5 days after surgery, then every 3 months till 2 years, then every 6 month till 3 years ]
    Measure the thioredoxin reductase activity in blood at the setting time point, before surgery, 3-5 days after surgery, after every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage ⅠA and low risk ⅠB. Blood will be taken before surgery, 3-5 days after surgery, before adjuvant chemotherapy, after two cycles of adjuvant chemotherapy, after every 3 months after adjuvant chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage high risk ⅠB IIA IIB and IIIA.


Secondary Outcome Measures:
  • Measure carcina embryonic antigen(CEA) level in blood [ Time Frame: blood should be taken before and 3-5 days after surgery, then every 3 months till 2 years, then every 6 month till 3 years ]
    Measure the carcina embryonic antigen(CEA) level in blood at the setting time point, before surgery, 3-5 days after surgery, after every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage ⅠA and low risk ⅠB. Blood will be taken before surgery, 3-5 days after surgery, before adjuvant chemotherapy, after two cycles of adjuvant chemotherapy, after every 3 months after adjuvant chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse in patients at stage high risk ⅠB IIA IIB and IIIA.


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

Enrollment: 165
Study Start Date: May 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
early staged non-small cell lung cancer
patients diagnosed as early staged non-small cell lung cancer and received surgery in HunanPTH

Detailed Description:
This is a cooperative research project in Thoracic Surgery Department and 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 in blood in staged(Ⅰ~ⅢA) non-small lung cancers, to study the warning relapse ability of thioredoxin reductase in blood. The secondary objective is to compare the warning relapse activity of blood thioredoxin reductase activity with carcinoembryonic antigen (CEA) in subjects who received surgery. Blood will be collected in subjects before surgery, 5 days after surgery, and every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse for the subjects at stage ⅠA and low risk ⅠB. Blood will be collected before surgery, 5 days after surgery, before adjuvant chemotherapy, after 2 circles of all adjuvant chemotherapy, then every 3 months after adjuvant chemotherapy till 2 years, and every 6 months till 3 years, or collect blood till tumor relapse for the subjects of high risk ⅠB~ⅢA, evaluation CT results every time collect blood samples.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 resectable non-small lung cancer and received surgery in Affiliated Cancer Hospital of xiangya School of Medicine Central South University, HunanPTH
Criteria

Inclusion Criteria:

  • Pathologically proven staged(Ⅰ~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass, fast pathology proved non-small cell lung cancer
  • Receive surgery in Thoracic Oncology department Affiliated Cancer Hospital of xiangya School of Medicine Central South University without contraindication of surgery
  • Tumor treatment naive(except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before)
  • Signed informed consent to provide blood and tissue for study

Exclusion Criteria:

  • Patients received antitumor treatment before
  • Patients with contraindication of surgery or patients who need adjuvant chemotherapy 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): NCT01991418


Locations
China, Hunan
Hunan Provincal Tumor Hospital
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
Principal Investigator: Nong Yang, MD Hunan Province Tumor Hospital
  More Information

Responsible Party: Nong Yang, chief, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT01991418     History of Changes
Other Study ID Numbers: TR002
EWSOTRILC ( Other Identifier: HunanPTH )
First Submitted: November 4, 2013
First Posted: November 25, 2013
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
carcina embryonic antigen

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