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Establishment of Patient Derived Cancer Cell Models to Interrogate Novel Molecular Targets in Metastatic Cancer

13. juni 2022 oppdatert av: Jeeyun Lee, Samsung Medical Center

With rapid advances in molecular oncology, the availability of preclinical in vitro cell models and in vivo animal models with specific genomic aberrations is critical for improved prediction of clinical outcomes in cancer patients. One of the most widely used preclinical models is conventional cell lines, such as the NCI-60 panel of cell lines;these cell lines are widely used in preclinical testing for novel targeted drugs, partially owing to the low expense and reduced labor associated with cell culture compared with other preclinical models, such as animal xenografts. However, recent studies have shown that accumulation of genetic aberrations in cancer cell lines occurs with increasing passage number. These models also lack the heterogeneity of tumors and do not exhibit a proper microenvironment, highlighting the limitations of cell-based models. Consistent with this, Johnson et al. demonstrated that in vivo activities of the cell lines within the NCI-60 panel did not closely correlate with corresponding human cancers.

Therefore, to better preserve the genomic integrity and tumor heterogeneity observed in patients, patient-derived xenograft (PDX) models are being used more frequently. PDX is generated by directly transplanting freshly resected patient tumors into immunocompromised murine hosts with or without an intermediate in vitro culture step. This PDX model is an improvement over cell lines because it can provide both an appropriate tumor microenvironment and heterogeneity of tumor cells. However, the engraftment success rates and growth rates of implanted tumors are highly variable depending on the tumor type, possibly due to insufficient numbers of hematopoietic cells and/or ineffective microenvironmental cues in the mouse stroma. The extent to which tumor cells from freshly resected tumors are able to withstand mechanical stresses and xenotransplantation barriers is also unclear. Furthermore, the use of PDX models for application in clinical oncology is limited owing to the time required for PDX establishment (> 4 months) since most patients with refractory cancer live less than 1 year. Recently, PDC line models have been suggested as an alternative preclinical model to be used as a prediction tool for preclinical drug sensitivity.

Therefore, in this study, the investigators aimed to overcome these potential barriers of pre-existing models by examining the capacity of PDC line models to recapitulate the histological and genomic features of primary patient tumors. In selected cases, the investigators screened drug sensitivity in vitro using PDC lines and compared the results with real-life clinical treatment outcomes.

Studieoversikt

Status

Rekruttering

Studietype

Observasjonsmessig

Registrering (Forventet)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Korea
      • Seoul, Korea, Korea, Republikken, 135-720
        • Rekruttering
        • Samsung Medical Center
        • Ta kontakt med:
          • yoon jeong ahn
          • Telefonnummer: 82-2-2148-7395
        • Hovedetterforsker:
          • Jeeyun Lee, MD, PhD

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

inclusion criteria are as follows: age ≥ 18 years; pathologically confirmed solid cancer; presence of metastatic lesion(s) not amenable to surgical treatment and having malignant effusion in the body cavity which needed to be drained by percutaneous methods for therapeutic purpose.

Beskrivelse

Inclusion Criteria:

  • Patients older than 18 years.
  • Patients with histologically confirmed cancer
  • Written informed consent form
  • Presence of metastatic lesion(s) not amenable to surgical treatment and having malignant effusion in the body cavity which needed to be drained by percutaneous methods for therapeutic purpose.

Exclusion Criteria:

  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
molecular profiling, patient derived cells

molecular profiling,patient derived cells sample and experimental methods-Blood sample,tumor tissue or primary cultures of human effusions.

Malignant ascites, pleural effusions, or pericardial effusions will be collected from patients with metastatic cancer.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
molecular screening(collected of blood,tumor tissue Malignant ascites, pleural effusions, or pericardial effusions will be analyzed)
Tidsramme: At the time of study entry.
To determine the feasibility of the use of patient derived tumor cell models - molecular profiling to direct targeted therapies in the treatment of refractory solid tumors
At the time of study entry.
The success rate of patient derived tumor cell model establishment
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Total overlevelse
Tidsramme: 2 år
2 år
Progresjonsfri overlevelse
Tidsramme: 2 år
2 år
Varighet av svar
Tidsramme: 2 år
2 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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 (Faktiske)

4. februar 2016

Primær fullføring (Forventet)

1. juni 2022

Studiet fullført (Forventet)

1. juni 2023

Datoer for studieregistrering

Først innsendt

3. januar 2016

Først innsendt som oppfylte QC-kriteriene

4. januar 2016

Først lagt ut (Anslag)

5. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2015-12-154

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. .

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