- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04636047
NGS-based Comprehensive Genomic ctDNA Panel in NSCLC With Immunotherapy
14. november 2020 oppdatert av: Lu Shun, Shanghai Chest Hospital
A Prospective Study on NGS-based Comprehensive Genomic ctDNA Panel in NSCLC Treated With Immunotherapy
Liquid biopsy based on next-generation sequencing (NGS) method has become an increasingly powerful detection tool for clinical research and practice.
As a companion diagnostic panel, circulating tumor DNA (ctDNA) assay has the considerable potential to detect the blood tumor mutation burden (bTMB), and bTMB calculated by ctDNA assay is regarded as a novel and promising biomarker for immunotherapy nowadays.
Though immune checkpoint inhibitors (ICIs) in immunotherapy are highly effective but can induce severe immune-related adverse events (irAEs), which cannot be better predicted in advance.
Meanwhile adoptive transfer of T cells transgenic for tumor-reactive T-cell receptors (TCR) is an attractive immunotherapeutic approach.
However, clinical translation is so far limited due to challenges in the identification of suitable target antigens as well as TCRs that are concurrent safe and efficient.
Definition of key characteristics relevant for effective and specific tumor rejection is essential to improve current TCR-based immunotherapy.
This research is to characterize in-depth TCRs derived from HLA-mismatched allogeneic repertoire targeting different myeloperoxidase (MPO)-derived peptides presented by the same HLA-restriction element.
Overall the purpose of this trial is to investigate the combined predictive biomarkers (including bTMB and HLA) related to the immunotherapy effects and the biomarker (TCR) associated with adverse reactions during immunotherapy and hold a predictive role, thus further benefit patients receiving immunotherapy, especially in the advanced stage lung cancer patients where tissue samples are unavailable.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Blood samples including the plasma and PBMC (peripheral blood mononuclear cell) from immunotherapy-naive lung cancer patients will be analyzed by CGP panel (OrigiMed, Inc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, bTMB, HLA, etc. Treatment methods and outcomes will be followed-up to inspect the clinical benefit and safety with CGP-panel analysis.
Studietype
Observasjonsmessig
Registrering (Forventet)
450
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xiaomin Niu
- Telefonnummer: 021-22200000-3403
- E-post: ar_tey@hotmail.com
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200030
- Rekruttering
- Shanghai Chest Hospital
-
Ta kontakt med:
- Xiaomin Niu
- E-post: ar_tey@hotmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
patients in Shanghai Chest Hospital
Beskrivelse
Inclusion Criteria:
- Participant aged 18 or above, and gender unrestricted
- Individual with pathologically diagnosed lung cancer
Exclusion Criteria:
- Patients with concomitant other tumors
- Individual with severe cardiopulmonary insufficiency and hypoproteinemia
- Women who were pregnant and were during their lactation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival (PFS)
Tidsramme: through the whole study period, an average of 3 years
|
PFS will be defined as the time from initial treatment to the time of disease progression or death
|
through the whole study period, an average of 3 years
|
|
Blood Tumor Mutational Burden (bTMB)
Tidsramme: halfway of the study, an average of 1 year
|
bTMB will be defined as the total number of detected somatic mutation counts in coding regions per million bases in plasma ctDNA
|
halfway of the study, an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Other biomarkers
Tidsramme: halfway of the study, an average of 1 year
|
The distribution and clinical applications including benefit and adverse reaction of biomarkers such as HLA, TCR and gene mutations in Chinese non-small cell lung cancer patients
|
halfway of the study, an average of 1 year
|
|
Clonality
Tidsramme: halfway of the study, an average of 1 year
|
The tumor clonality in Chinese non-small cell lung cancer
|
halfway of the study, an average of 1 year
|
|
Overall survival (OS)
Tidsramme: through the whole study period, an average of 3 years
|
OS will be defined as the time from cancer diagnosed time to the time of death
|
through the whole study period, an average of 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. november 2020
Primær fullføring (Forventet)
1. februar 2023
Studiet fullført (Forventet)
1. august 2023
Datoer for studieregistrering
Først innsendt
28. september 2020
Først innsendt som oppfylte QC-kriteriene
14. november 2020
Først lagt ut (Faktiske)
19. november 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ShanghaiChest0016
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .