NCT01980212

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

November 4, 2013

Last Update Submit

March 24, 2020

Conditions

Keywords

non-small cell lung cancerthioredoxin reductase

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To measure the carcinoembryonic antigen (CEA) level in blood

    may 2013- may 2014 (1 year)

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients received antitumor treatment before
  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

3-4 ml whole blood was obtained and then centrifuged and stored at -20 ℃

MeSH Terms

Conditions

Disease ProgressionCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nong Yang, MD

    Hunan Province Tumor Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations