- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02466113
A 6 microRNA Tool for Stratifying Stage II Colon Cancer of Receiving Adjuvant Chemotherapy
8. juni 2015 opdateret af: Wu Song, First Affiliated Hospital, Sun Yat-Sen University
A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Chemotherapy of Stage II Colon Cancer Based on a 6 microRNA Stratified Tool
Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is still on debate.MicroRNA(miRNA) is a promising tool.
Investigators invented a tool consisting of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was effective to identify one should accept adjuvant chemotherapy or not.
Here investigators randomly assign patients to be assessed by classical pathological features or the miRNA tool of determining who should accept chemotherapy.
Disease free survival and overall survival are the end points of observation.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Investigators randomly assign patients to be assessed by classical pathological features(control group) or the miRNA tool(experimental group).
Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and <12 lymph nodes examined.MicroRNA tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215.
Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miR-21-5p)+(0.086×status of miR-20a-5p)+(0.240×status of miR-103a-3p)+(0.095×status of miR-106b-5p)-(0.238×status of miR-143-5p)-(0.237×status of miR-215),low expression status equals 0 and high expression status equals 1).
Investigators defined high risk patient if had any pathological features in control group or the score larger than 1 in the experimental group ,the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
Primary endpoint is the disease free survival and overall survival.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
430
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zehong Chen, master
- Telefonnummer: +8613751773229
- E-mail: Stevenchen8@qq.com
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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- The informed consent has been obtained from the patient.
- With confirmed diagnosis of stage II colon cancer.
- With moderate/good ECOG health rating (PS): 0-1 score.
- The patient receive no anti-cancer treatment before primary surgery.
- The patient receive radical operation for colon cancer with negative margin.
Exclusion Criteria:
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
- Pregnant woman or lactating woman.
- With contraindication to receive adjuvant chemotherapy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: An experimental group
A 6 microRNA stratified tool is applied in this group.Investigators defined high risk patient and low risk patient according to the microRNA stratified tool.The high risk group should receive adjuvant chemotherapy while the low risk group observation.
|
Investigators randomly assign patients to be assessed by a 6 microRNA stratified tool.
MicroRNA(miRNA) tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215.
Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miRNA-21-5p)+(0.086×status of miRNA-20a-5p)+(0.240×status of miRNA-103a-3p)+(0.095×status of miRNA-106b-5p)-(0.238×status of miRNA-143-5p)-(0.237×status of miRNA-215),low expression status equals 0 and high expression status equals 1).
Investigators defined high risk patient if their score larger than 1, the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
|
Andet: A control group
A classic stratified tool is applied in this group.
Investigators defined high risk and low risk patient according to classical pathological features.The high risk group should receive adjuvant chemotherapy while the low risk group observation.
|
Investigators randomly assign patients to be assessed by by classical pathological features.
Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and <12 lymph nodes examined.
Investigators defined high risk patient if they had any pathological features, the others as low risk patient.
The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Disease free survival
Tidsramme: 3 years or 5 years
|
3 years or 5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall survival
Tidsramme: 5 years or 10 years
|
5 years or 10 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studieleder: Wu Song, MD, First Affiliated Hospital, Sun Yat-Sen University
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. januar 2016
Primær færdiggørelse (Forventet)
1. januar 2026
Studieafslutning (Forventet)
1. januar 2026
Datoer for studieregistrering
Først indsendt
30. april 2015
Først indsendt, der opfyldte QC-kriterier
8. juni 2015
Først opslået (Skøn)
9. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015[28]
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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