NCT01991418

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Typical duration 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

Click on a node to explore related trials.

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
21 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

November 4, 2013

Last Update Submit

February 14, 2016

Conditions

Non-small Cell Lung Cancer Stage INon-small Cell Lung Cancer Stage IINon-small Cell Lung Cancer Stage IIIA

Keywords

non-small cell lung cancerthioredoxin reductasecarcina embryonic antigen

Outcome Measures

Primary Outcomes (1)

  • Measure the thioredoxin reductase activity in blood

    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.

    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

Secondary Outcomes (1)

  • Measure carcina embryonic antigen(CEA) level in blood

    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

Study Arms (1)

early staged non-small cell lung cancer

patients diagnosed as early staged non-small cell lung cancer and received surgery in HunanPTH

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nong Yang, MD

    Hunan Province Tumor Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 25, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

CN(1)