Advanced Non-small Cell Lung CancerNCT01980212
Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer
An observational study of Advanced Non-small Cell Lung Cancer and First Line Treatment, run by Hunan Province Tumor Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer, First Line Treatment, Thioredoxin Reductase Activity
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2013to 1 Dec 2018
- 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 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
Who may be able to join
- 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
Who cannot join
- Patients received antitumor treatment before
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer
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
Read the 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.
- Conditions
- Advanced Non-small Cell Lung Cancer, First Line Treatment, Thioredoxin Reductase Activity, Carcinoembryonic Antigen, Progression
- Keywords
- non-small cell lung cancer, thioredoxin reductase
- Medical subject headings
- Disease Progression, 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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: may 2013 - may 2014 (1 year)
Secondary outcomes (1)
To measure the carcinoembryonic antigen (CEA) level in blood
Measure the CEA level every time compared with thioredoxin reductase activity
Measured: may 2013- may 2014 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start1 May 2013
- Primary completion1 Dec 2016
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Nong Yang, MD, Study chair, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980212
- Sponsor's protocol ID
- TRSTILC
- Status last verified
- Mar 2020
- First submitted
- 4 Nov 2013
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Thioredoxin Reductase Activity Research in First-line Chemotherapy Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01980212
- Acronym / sponsor ID
- TRSTILC
- Conditions
- Advanced Non-small Cell Lung Cancer, First Line Treatment, Thioredoxin Reductase Activity, Carcinoembryonic Antigen, Progression
- Keywords
- non-small cell lung cancer, thioredoxin reductase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 8 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 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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients received antitumor treatment before
- Patients 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
To measure the thioredoxin reductase activity in blood
Time frame: 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.
1 secondary outcome
To measure the carcinoembryonic antigen (CEA) level in blood
Time frame: may 2013- may 2014 (1 year)
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 26 Mar 2020.
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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 study chair
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 Advanced Non-small Cell Lung Cancer and First Line Treatment, 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 3 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 26 Mar 2020. 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?
To measure the thioredoxin reductase activity in blood (time frame: may 2013 - may 2014 (1 year)). 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 26 Mar 2020.