Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)
14. februar 2016 opdateret af: 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
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
165
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Provincal Tumor Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients diagnosed with resectable non-small lung cancer and received surgery in Affiliated Cancer Hospital of xiangya School of Medicine Central South University, HunanPTH
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
early staged non-small cell lung cancer
patients diagnosed as early staged non-small cell lung cancer and received surgery in HunanPTH
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measure the thioredoxin reductase activity in blood
Tidsramme: 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 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measure carcina embryonic antigen(CEA) level in blood
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2013
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
4. november 2013
Først indsendt, der opfyldte QC-kriterier
18. november 2013
Først opslået (Skøn)
25. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TR002
- EWSOTRILC (Anden identifikator: HunanPTH)
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