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Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

26. september 2016 oppdatert av: Memorial Sloan Kettering Cancer Center

A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

The purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA in a gene is damaged in a way that changes the genetic message carried by that gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

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

Studiesteder

Forente stater
- New Jersey
  - Basking Ridge, New Jersey, Forente stater
    - Memoral Sloan Kettering Cancer Center
- New York
  - Commack, New York, Forente stater, 11725
    - Memorial Sloan Kettering Cancer Center @ Suffolk
  - New York, New York, Forente stater, 10065
    - Memorial Sloan Kettering Cancer Center
  - Rockville Centre, New York, Forente stater
    - Memorial Sloan Kettering at Mercy Medical Center
  - Sleepy Hollow, New York, Forente stater, 10591
    - Memoral Sloan Kettering Cancer Center at Phelps
  - West Harrison, New York, Forente stater, 10604
    - Memorial Sloan Kettering West Harrison

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

Ikke-sannsynlighetsprøve

Studiepopulasjon

MSKCC clinics

Beskrivelse

Inclusion Criteria:

Lung cancer:

For patients participating in Part A (initial testing) and Part B (serial testing):

Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic therapy.
Patients must have had or intend to have EGFR mutation testing (specifically including exon 19 deletions and L858R) performed on their tumor with results available from a CLIA certified laboratory.
≥ 18 years of age

Specific to patients participating in Part B (serial testing):

Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory.
Must be within 3 months of their diagnosis of metastatic lung cancer.
Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol.

Colorectal Cancer:

For patients participating in Part A (initial testing) and Part B (serial testing):

Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-EGFR based therapy.
Patients must have had or intend to have RAS/RAF mutation testing on their tumor with results available from a CLIA certified laboratory. For the patients who recently progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment).
>18 years of age

Specific to patients participating in Part B (serial testing):

Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing results available from a CLIA certified laboratory.
Must be within 3 months of their diagnosis of metastatic colorectal cancer.

Exclusion Criteria:

lung cancer and colorectal cancer

Comorbidities that would prohibit or make serial urine collection difficult or impossible

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Lung and Colorectal cancer patients Eligible people who consent to participation will provide urine (both in lung cancer and colorectal cancer) and blood (in lung cancer only) samples at pre-specified times.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
EGFR detection in urinary cell free DNA [cfDNA] Tidsramme: 2 years	The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer	2 years
To validate the Trovagene urine assay Tidsramme: 2 years	urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.	2 years

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA) Tidsramme: 2 years	The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.	2 years

Samarbeidspartnere og etterforskere

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

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbeidspartnere

Cardiff Oncology

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Memorial Sloan Kettering Cancer Center

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

1. juli 2014

Primær fullføring (Faktiske)

1. september 2016

Datoer for studieregistrering

Først innsendt

7. juli 2014

Først innsendt som oppfylte QC-kriteriene