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Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes

8. oktober 2021 opdateret af: UNC Lineberger Comprehensive Cancer Center

LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes

The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

Undersøgelsestype

Observationel

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Cancer patients with liver and/or lung metastasis who will receive systemic treatment.

Beskrivelse

Inclusion Criteria:

  • Patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. Patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts:

    • Patients had a tumor or liquid biopsy with molecular analysis (genomic analysis or other type of molecular characterization) resulting in a therapeutic target with planned targeted therapy by the patient's treating physician.
    • Gastric cancer patients who have failed the first and second line chemotherapy.
    • Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment.
  • Scheduled to initiate systemic treatment for management of their disease. The systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy.
  • ≥18 years of age
  • Written informed consent obtained and signed
  • Able to have blood collection without excessive difficulty

Exclusion Criteria:

  • Patient unwilling or unable to complete informed consent
  • Currently pregnant or lactating women
  • Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician

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
Intervention / Behandling
Metastatic Cancer Pts Receiving Molecularly Targeted Therapy
Metastatic cancer patients (with liver and/or lung metastasis) who will receive molecularly targeted therapy based on genomic testing data
Andet: Blood Draw
A blood sample will be collected once, prior to treatment.
GI Cancer Pts
Gastrointestinal cancer patients (with liver and/or lung metastasis) who will receive 3rd line treatments or enrolled on a targeted therapy treatment trial
Andet: Blood Draw
A blood sample will be collected once, prior to treatment.
Bladder Cancer Pts
Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment
Andet: Blood Draw
A blood sample will be collected once, prior to treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between treatment response in CTCs and in vivo
Tidsramme: Initiation of trial to 24 months post-initiation
To estimate the agreement between CTC cultures' response to treatment, dichotomized as either yes or no response, to the clinical response in patients to treatment, dichotomized as either progressive disease (PD) versus complete response (CR), partial response (PR), or stable disease (SD)
Initiation of trial to 24 months post-initiation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity, specificity, and predictive values of CTC cultures' treatment response
Tidsramme: Initiation of trial to 24 months post-initiation
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)
Initiation of trial to 24 months post-initiation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Andrew Z Wang, MD, UNC Chapel Hill

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 (Forventet)

1. juni 2021

Primær færdiggørelse (Forventet)

1. juni 2023

Studieafslutning (Forventet)

1. juni 2023

Datoer for studieregistrering

Først indsendt

19. februar 2020

Først indsendt, der opfyldte QC-kriterier

19. februar 2020

Først opslået (Faktiske)

21. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LCCC1938

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Blood Draw

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner