Non-small Cell Lung CancerTRCRLCNCT01985113
Correlation Research of Thioredoxin Reductase in Lung Cancer
An observational study of Non-small Cell Lung Cancer and Benign Neoplasm of Lung, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
In pre-clinical study the investigators 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, so the investigators hypothesis that this is due to tumor cells loading of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Benign Neoplasm of Lung
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with early staged NSCLC and lung benign lesion Patients show resectable lung mass in CT scan, suspected lung cancer and receive surgery in Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
Who may be able to join
- Pathologically proven staged(Ⅰ~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass
- Receive surgery in Thoracic Oncology department Hunan Tumor Hospital without contraindication of surgery
- Malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
- Signed informed consent about providing blood and tissue for study
Who cannot join
- Patients have received antitumor treatment
- Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Study of Blood and Tissue Thioredoxin Reductase Activity in Early Stage On-small Cell Lung Cancers
In pre-clinical study the investigators 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, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.
Read the 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 using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early staged(Ⅰ~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. The secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.
- Keywords
- thioredoxin reductase, non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| early staged non-small cell lung cancers | patients who diagnosed as early staged non-small cell lung cancer after surgery | |
| lung benign mass patients | patients who diagnosed as lung benign mass after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the thioredoxin reductase activity in blood, tumor and pericarcinomatous tissue
3-4 ml blood should be taken and centrifuged in 30 mins, then the serum should be stored at -20 degree, then serum thioredoxin reductase activity should be measured in one month. Tumor and pericarcinomatous tissues should be stored at -180 degree and enzyme activity should be measured within one month
Measured: blood should be taken in 2 days before surgery, tumor and pericarcinomatous tissues should be stored and tested in one month
Secondary outcomes (2)
Measure the difference of thioredoxin reductase activity between lung cancer tissue and lung benign mass
Tumor tissue or lung benign mass obtained during surgery should be stored at -180 degree within 5 mins and enzyme activity should be measured within one month.
Measured: Tumor tissue or lung benign mass obtained during surgery should be stored at -180 degree within 5 mins and enzyme activity should be measured within one month
Measure the thioredoxin reductase mRNA and protein expression in tumor and pericarcimomatous tissue
Tumor tissue or pericarcimomatous tissue should be stored at -180 degree, then qRT-PCR should be done within 3 months
Measured: Tumor tissue or pericarcimomatous tissue should be stored at -180 degree, then qRT-PCR should be done within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nong Yang, Hunan Province Tumor Hospital
- Investigators
- Nong Yang, MD, Principal investigator, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985113
- Sponsor's protocol ID
- TR001
- Other IDs
- TRRFLC1
- Acronym
- TRCRLC
- Status last verified
- Feb 2016
- First submitted
- 4 Nov 2013
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study of Blood and Tissue Thioredoxin Reductase Activity in Early Stage On-small Cell Lung Cancers
- ClinicalTrials.gov ID
- NCT01985113
- Acronym / sponsor ID
- TRCRLC / TR001
- Keywords
- thioredoxin reductase, non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In pre-clinical study the investigators 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, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.
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 using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early staged(Ⅰ~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. The secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early staged non-small cell lung cancers | – | –patients who diagnosed as early staged non-small cell lung cancer after surgery |
| lung benign mass patients | – | –patients who diagnosed as lung benign mass after surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early staged NSCLC and lung benign lesion Patients show resectable lung mass in CT scan, suspected lung cancer and receive surgery in Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
Key inclusion criteria (4 listed)
- Pathologically proven staged(Ⅰ~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass
- Receive surgery in Thoracic Oncology department Hunan Tumor Hospital without contraindication of surgery
- Malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
- Signed informed consent about providing blood and tissue for study
Key exclusion criteria (3 listed)
- Patients have received antitumor treatment
- Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
- Pregnant or breast feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measure the thioredoxin reductase activity in blood, tumor and pericarcinomatous tissue
Time frame: blood should be taken in 2 days before surgery, tumor and pericarcinomatous tissues should be stored and tested in one month
3-4 ml blood should be taken and centrifuged in 30 mins, then the serum should be stored at -20 degree, then serum thioredoxin reductase activity should be measured in one month. Tumor and pericarcinomatous tissues should be stored at -180 degree and enzyme activity should be measured within one month
2 secondary outcomes
Measure the difference of thioredoxin reductase activity between lung cancer tissue and lung benign mass
Time frame: Tumor tissue or lung benign mass obtained during surgery should be stored at -180 degree within 5 mins and enzyme activity should be measured within one month
Measure the thioredoxin reductase mRNA and protein expression in tumor and pericarcimomatous tissue
Time frame: Tumor tissue or pericarcimomatous tissue should be stored at -180 degree, then qRT-PCR should be done within 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nong Yang, MD principal investigator
Hunan Province Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Benign Neoplasm of Lung, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the thioredoxin reductase activity in blood, tumor and pericarcinomatous tissue (time frame: blood should be taken in 2 days before surgery, tumor and pericarcinomatous tissues should be stored and tested in one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.