Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)
14 februari 2016 uppdaterad av: Nong Yang, Hunan Province Tumor Hospital
Early Warning Study of Plasma Thioredoxin Reductase Activity in Non-small Cell Lung Cancers Received Surgery
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
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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 in blood in staged(Ⅰ~ⅢA) non-small lung cancers, to study the warning relapse ability of thioredoxin reductase in blood.
The secondary objective is to compare the warning relapse activity of blood thioredoxin reductase activity with carcinoembryonic antigen (CEA) in subjects who received surgery.
Blood will be collected in subjects before surgery, 5 days after surgery, and every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse for the subjects at stage ⅠA and low risk ⅠB.
Blood will be collected before surgery, 5 days after surgery, before adjuvant chemotherapy, after 2 circles of all adjuvant chemotherapy, then every 3 months after adjuvant chemotherapy till 2 years, and every 6 months till 3 years, or collect blood till tumor relapse for the subjects of high risk ⅠB~ⅢA, evaluation CT results every time collect blood samples.
Studietyp
Observationell
Inskrivning (Faktisk)
165
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Provincal Tumor Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients diagnosed with resectable non-small lung cancer and received surgery in Affiliated Cancer Hospital of xiangya School of Medicine Central South University, HunanPTH
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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early staged non-small cell lung cancer
patients diagnosed as early staged non-small cell lung cancer and received surgery in HunanPTH
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Measure the thioredoxin reductase activity in blood
Tidsram: 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
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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.
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measure carcina embryonic antigen(CEA) level in blood
Tidsram: 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
|
Measure the carcina embryonic antigen(CEA) level 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2013
Primärt slutförande (Faktisk)
1 februari 2016
Avslutad studie (Faktisk)
1 februari 2016
Studieregistreringsdatum
Först inskickad
4 november 2013
Först inskickad som uppfyllde QC-kriterierna
18 november 2013
Första postat (Uppskatta)
25 november 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TR002
- EWSOTRILC (Annan identifierare: HunanPTH)
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