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

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01980212
Collaborator
(none)
500
Enrollment
1
Location
67
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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
    Actual Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer
    Actual Study Start Date :
    May 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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 [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 [may 2013- may 2014 (1 year)]

      Measure the CEA level every time compared with thioredoxin reductase activity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hunan Provincal Tumor Hospital Changsha Hunan China 410013

    Sponsors and Collaborators

    • Hunan Province Tumor Hospital

    Investigators

    • Study Chair: Nong Yang, MD, Hunan Province Tumor Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongchang Zhang, chief, Hunan Province Tumor Hospital
    ClinicalTrials.gov Identifier:
    NCT01980212
    Other Study ID Numbers:
    • TRSTILC
    First Posted:
    Nov 8, 2013
    Last Update Posted:
    Mar 26, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Yongchang Zhang, chief, Hunan Province Tumor Hospital
    non-small cell lung cancer
    thioredoxin reductase
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Mar 26, 2020